ZIMMER TRABECULAR METAL HUMERAL STEM
Report
- Report Number
- 1822565-2010-00727
- Event Type
- Malfunction
- Date Received
- September 17, 2010
- Date of Event
- September 12, 2007
- Report Date
- September 13, 2007
- Manufacturer
- ZIMMER INC
- Product Code
- HSD
- Removal / Correction Number
- 1822565-7/26/2010-006-R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
EVALUATION SUMMARY: DURING TRABECULAR METAL HUMERAL AND THE TRABECULAR METAL REVERSE SHOULDER PROCEDURES, INSTRUMENTS PREPARE THE BONE FOR A TOLERANCE RANGE FROM SLIGHT PRESSFIT TO SLIGHT CLEARANCE. BECAUSE THESE STEMS HAVE PROXIMAL TRABECULAR METAL COMBINED WITH A PROXIMAL TAPER THEY ACHIEVE ADEQUATE STABILITY THROUGH PROXIMAL FIXATION ALONE. IT HAS BEEN DETERMINED THAT DISTAL PRESS IS NOT REQUIRED AND THAT DISTAL PRESS COULD LEAD TO DIFFICULTY SEATING THE IMPLANT DEPENDANT ON BONE QUALITY, HUMERAL GEOMETRY, AND SURGEON REAMING. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE OCCURRENCE SUGGESTS THAT THE EVENT IS RELATED TO THE ISSUES FOR WHICH ZIMMER IS IMPLEMENTING CORRECTIVE ACTION. REFERENCE REMOVAL REPORT 1822565-7/26/2010-006-R FOR ADDITIONAL INFORMATION REGARDING THE CORRECTIVE ACTION TAKEN. DEVICE MEASUREMENTS MEET PRINTS SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.
EVALUATION SUMMARY: DURING TRABECULAR METAL HUMERAL AND THE TRABECULAR METAL REVERSE SHOULDER PROCEDURES, INSTRUMENTS PREPARE THE BONE FOR A TOLERANCE RANGE FROM SLIGHT PRESSFIT TO SLIGHT CLEARANCE. BECAUSE THESE STEMS HAVE PROXIMAL TRABECULAR METAL COMBINED WITH A PROXIMAL TAPER THEY ACHIEVE ADEQUATE STABILITY THROUGH PROXIMAL FIXATION ALONE. IT HAS BEEN DETERMINED THAT DISTAL PRESS IS NOT REQUIRED AND THAT DISTAL PRESS COULD LEAD TO DIFFICULTY SEATING THE IMPLANT DEPENDANT ON BONE QUALITY, HUMERAL GEOMETRY, AND SURGEON REAMING. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE OCCURRENCE SUGGESTS THAT THE EVENT IS RELATED TO THE ISSUES FOR WHICH ZIMMER IS IMPLEMENTING CORRECTIVE ACTION. REFERENCE REMOVAL REPORT 1822565-7/26/2010-006-R FOR ADDITIONAL INFORMATION REGARDING THE CORRECTIVE ACTION TAKEN. DEVICE MEASUREMENTS MEET PRINTS SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.
EVALUATION SUMMARY: DURING TRABECULAR METAL HUMERAL AND THE TRABECULAR METAL REVERSE SHOULDER PROCEDURES, INSTRUMENTS PREPARE THE BONE FOR A TOLERANCE RANGE FROM SLIGHT PRESSFIT TO SLIGHT CLEARANCE. BECAUSE THESE STEMS HAVE PROXIMAL TRABECULAR METAL COMBINED WITH A PROXIMAL TAPER THEY ACHIEVE ADEQUATE STABILITY THROUGH PROXIMAL FIXATION ALONE. IT HAS BEEN DETERMINED THAT DISTAL PRESS IS NOT REQUIRED AND THAT DISTAL PRESS COULD LEAD TO DIFFICULTY SEATING THE IMPLANT DEPENDANT ON BONE QUALITY, HUMERAL GEOMETRY, AND SURGEON REAMING. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE OCCURRENCE SUGGESTS THAT THE EVENT IS RELATED TO THE ISSUES FOR WHICH ZIMMER IS IMPLEMENTING CORRECTIVE ACTION. REFERENCE REMOVAL REPORT 1822565-7/26/2010-006-R FOR ADDITIONAL INFORMATION REGARDING THE CORRECTIVE ACTION TAKEN. DEVICE MEASUREMENTS MEET PRINTS SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.
EVALUATION SUMMARY: DURING TRABECULAR METAL HUMERAL AND THE TRABECULAR METAL REVERSE SHOULDER PROCEDURES, INSTRUMENTS PREPARE THE BONE FOR A TOLERANCE RANGE FROM SLIGHT PRESSFIT TO SLIGHT CLEARANCE. BECAUSE THESE STEMS HAVE PROXIMAL TRABECULAR METAL COMBINED WITH A PROXIMAL TAPER THEY ACHIEVE ADEQUATE STABILITY THROUGH PROXIMAL FIXATION ALONE. IT HAS BEEN DETERMINED THAT DISTAL PRESS IS NOT REQUIRED AND THAT DISTAL PRESS COULD LEAD TO DIFFICULTY SEATING THE IMPLANT DEPENDANT ON BONE QUALITY, HUMERAL GEOMETRY, AND SURGEON REAMING. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE OCCURRENCE SUGGESTS THAT THE EVENT IS RELATED TO THE ISSUES FOR WHICH ZIMMER IS IMPLEMENTING CORRECTIVE ACTION. REFERENCE REMOVAL REPORT 1822565-7/26/2010-006-R FOR ADDITIONAL INFORMATION REGARDING THE CORRECTIVE ACTION TAKEN. DEVICE MEASUREMENTS MEET PRINTS SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.
EVALUATION SUMMARY: DURING TRABECULAR METAL HUMERAL AND THE TRABECULAR METAL REVERSE SHOULDER PROCEDURES, INSTRUMENTS PREPARE THE BONE FOR A TOLERANCE RANGE FROM SLIGHT PRESSFIT TO SLIGHT CLEARANCE. BECAUSE THESE STEMS HAVE PROXIMAL TRABECULAR METAL COMBINED WITH A PROXIMAL TAPER THEY ACHIEVE ADEQUATE STABILITY THROUGH PROXIMAL FIXATION ALONE. IT HAS BEEN DETERMINED THAT DISTAL PRESS IS NOT REQUIRED AND THAT DISTAL PRESS COULD LEAD TO DIFFICULTY SEATING THE IMPLANT DEPENDANT ON BONE QUALITY, HUMERAL GEOMETRY, AND SURGEON REAMING. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE OCCURRENCE SUGGESTS THAT THE EVENT IS RELATED TO THE ISSUES FOR WHICH ZIMMER IS IMPLEMENTING CORRECTIVE ACTION. REFERENCE REMOVAL REPORT 1822565-7/26/2010-006-R FOR ADDITIONAL INFORMATION REGARDING THE CORRECTIVE ACTION TAKEN. DEVICE MEASUREMENTS MEET PRINTS SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.
EVALUATION SUMMARY: DURING TRABECULAR METAL HUMERAL AND THE TRABECULAR METAL REVERSE SHOULDER PROCEDURES, INSTRUMENTS PREPARE THE BONE FOR A TOLERANCE RANGE FROM SLIGHT PRESSFIT TO SLIGHT CLEARANCE. BECAUSE THESE STEMS HAVE PROXIMAL TRABECULAR METAL COMBINED WITH A PROXIMAL TAPER THEY ACHIEVE ADEQUATE STABILITY THROUGH PROXIMAL FIXATION ALONE. IT HAS BEEN DETERMINED THAT DISTAL PRESS IS NOT REQUIRED AND THAT DISTAL PRESS COULD LEAD TO DIFFICULTY SEATING THE IMPLANT DEPENDANT ON BONE QUALITY, HUMERAL GEOMETRY, AND SURGEON REAMING. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE OCCURRENCE SUGGESTS THAT THE EVENT IS RELATED TO THE ISSUES FOR WHICH ZIMMER IS IMPLEMENTING CORRECTIVE ACTION. REFERENCE REMOVAL REPORT 1822565-7/26/2010-006-R FOR ADDITIONAL INFORMATION REGARDING THE CORRECTIVE ACTION TAKEN. DEVICE MEASUREMENTS MEET PRINTS SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.
EVALUATION SUMMARY: DURING TRABECULAR METAL HUMERAL AND THE TRABECULAR METAL REVERSE SHOULDER PROCEDURES, INSTRUMENTS PREPARE THE BONE FOR A TOLERANCE RANGE FROM SLIGHT PRESSFIT TO SLIGHT CLEARANCE. BECAUSE THESE STEMS HAVE PROXIMAL TRABECULAR METAL COMBINED WITH A PROXIMAL TAPER THEY ACHIEVE ADEQUATE STABILITY THROUGH PROXIMAL FIXATION ALONE. IT HAS BEEN DETERMINED THAT DISTAL PRESS IS NOT REQUIRED AND THAT DISTAL PRESS COULD LEAD TO DIFFICULTY SEATING THE IMPLANT DEPENDANT ON BONE QUALITY, HUMERAL GEOMETRY, AND SURGEON REAMING. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE OCCURRENCE SUGGESTS THAT THE EVENT IS RELATED TO THE ISSUES FOR WHICH ZIMMER IS IMPLEMENTING CORRECTIVE ACTION. REFERENCE REMOVAL REPORT 1822565-7/26/2010-006-R FOR ADDITIONAL INFORMATION REGARDING THE CORRECTIVE ACTION TAKEN. DEVICE MEASUREMENTS MEET PRINTS SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.
EVALUATION SUMMARY: DURING TRABECULAR METAL HUMERAL AND THE TRABECULAR METAL REVERSE SHOULDER PROCEDURES, INSTRUMENTS PREPARE THE BONE FOR A TOLERANCE RANGE FROM SLIGHT PRESSFIT TO SLIGHT CLEARANCE. BECAUSE THESE STEMS HAVE PROXIMAL TRABECULAR METAL COMBINED WITH A PROXIMAL TAPER THEY ACHIEVE ADEQUATE STABILITY THROUGH PROXIMAL FIXATION ALONE. IT HAS BEEN DETERMINED THAT DISTAL PRESS IS NOT REQUIRED AND THAT DISTAL PRESS COULD LEAD TO DIFFICULTY SEATING THE IMPLANT DEPENDANT ON BONE QUALITY, HUMERAL GEOMETRY, AND SURGEON REAMING. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE OCCURRENCE SUGGESTS THAT THE EVENT IS RELATED TO THE ISSUES FOR WHICH ZIMMER IS IMPLEMENTING CORRECTIVE ACTION. REFERENCE REMOVAL REPORT 1822565-7/26/2010-006-R FOR ADDITIONAL INFORMATION REGARDING THE CORRECTIVE ACTION TAKEN. DEVICE MEASUREMENTS MEET PRINTS SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.
EVALUATION SUMMARY: DURING TRABECULAR METAL HUMERAL AND THE TRABECULAR METAL REVERSE SHOULDER PROCEDURES, INSTRUMENTS PREPARE THE BONE FOR A TOLERANCE RANGE FROM SLIGHT PRESSFIT TO SLIGHT CLEARANCE. BECAUSE THESE STEMS HAVE PROXIMAL TRABECULAR METAL COMBINED WITH A PROXIMAL TAPER THEY ACHIEVE ADEQUATE STABILITY THROUGH PROXIMAL FIXATION ALONE. IT HAS BEEN DETERMINED THAT DISTAL PRESS IS NOT REQUIRED AND THAT DISTAL PRESS COULD LEAD TO DIFFICULTY SEATING THE IMPLANT DEPENDANT ON BONE QUALITY, HUMERAL GEOMETRY, AND SURGEON REAMING. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE OCCURRENCE SUGGESTS THAT THE EVENT IS RELATED TO THE ISSUES FOR WHICH ZIMMER IS IMPLEMENTING CORRECTIVE ACTION. REFERENCE REMOVAL REPORT 1822565-7/26/2010-006-R FOR ADDITIONAL INFORMATION REGARDING THE CORRECTIVE ACTION TAKEN. DEVICE MEASUREMENTS MEET PRINTS SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.
EVALUATION SUMMARY: DURING TRABECULAR METAL HUMERAL AND THE TRABECULAR METAL REVERSE SHOULDER PROCEDURES, INSTRUMENTS PREPARE THE BONE FOR A TOLERANCE RANGE FROM SLIGHT PRESSFIT TO SLIGHT CLEARANCE. BECAUSE THESE STEMS HAVE PROXIMAL TRABECULAR METAL COMBINED WITH A PROXIMAL TAPER THEY ACHIEVE ADEQUATE STABILITY THROUGH PROXIMAL FIXATION ALONE. IT HAS BEEN DETERMINED THAT DISTAL PRESS IS NOT REQUIRED AND THAT DISTAL PRESS COULD LEAD TO DIFFICULTY SEATING THE IMPLANT DEPENDANT ON BONE QUALITY, HUMERAL GEOMETRY, AND SURGEON REAMING. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE OCCURRENCE SUGGESTS THAT THE EVENT IS RELATED TO THE ISSUES FOR WHICH ZIMMER IS IMPLEMENTING CORRECTIVE ACTION. REFERENCE REMOVAL REPORT 1822565-7/26/2010-006-R FOR ADDITIONAL INFORMATION REGARDING THE CORRECTIVE ACTION TAKEN. DEVICE MEASUREMENTS MEET PRINTS SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.
EVALUATION SUMMARY: DURING TRABECULAR METAL HUMERAL AND THE TRABECULAR METAL REVERSE SHOULDER PROCEDURES, INSTRUMENTS PREPARE THE BONE FOR A TOLERANCE RANGE FROM SLIGHT PRESSFIT TO SLIGHT CLEARANCE. BECAUSE THESE STEMS HAVE PROXIMAL TRABECULAR METAL COMBINED WITH A PROXIMAL TAPER THEY ACHIEVE ADEQUATE STABILITY THROUGH PROXIMAL FIXATION ALONE. IT HAS BEEN DETERMINED THAT DISTAL PRESS IS NOT REQUIRED AND THAT DISTAL PRESS COULD LEAD TO DIFFICULTY SEATING THE IMPLANT DEPENDANT ON BONE QUALITY, HUMERAL GEOMETRY, AND SURGEON REAMING. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE OCCURRENCE SUGGESTS THAT THE EVENT IS RELATED TO THE ISSUES FOR WHICH ZIMMER IS IMPLEMENTING CORRECTIVE ACTION. REFERENCE REMOVAL REPORT 1822565-7/26/2010-006-R FOR ADDITIONAL INFORMATION REGARDING THE CORRECTIVE ACTION TAKEN. DEVICE MEASUREMENTS MEET PRINTS SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.
EVALUATION SUMMARY: DURING TRABECULAR METAL HUMERAL AND THE TRABECULAR METAL REVERSE SHOULDER PROCEDURES, INSTRUMENTS PREPARE THE BONE FOR A TOLERANCE RANGE FROM SLIGHT PRESSFIT TO SLIGHT CLEARANCE. BECAUSE THESE STEMS HAVE PROXIMAL TRABECULAR METAL COMBINED WITH A PROXIMAL TAPER THEY ACHIEVE ADEQUATE STABILITY THROUGH PROXIMAL FIXATION ALONE. IT HAS BEEN DETERMINED THAT DISTAL PRESS IS NOT REQUIRED AND THAT DISTAL PRESS COULD LEAD TO DIFFICULTY SEATING THE IMPLANT DEPENDANT ON BONE QUALITY, HUMERAL GEOMETRY, AND SURGEON REAMING. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE OCCURRENCE SUGGESTS THAT THE EVENT IS RELATED TO THE ISSUES FOR WHICH ZIMMER IS IMPLEMENTING CORRECTIVE ACTION. REFERENCE REMOVAL REPORT 1822565-7/26/2010-006-R FOR ADDITIONAL INFORMATION REGARDING THE CORRECTIVE ACTION TAKEN. DEVICE MEASUREMENTS MEET PRINTS SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.
EVALUATION SUMMARY: DURING TRABECULAR METAL HUMERAL AND THE TRABECULAR METAL REVERSE SHOULDER PROCEDURES, INSTRUMENTS PREPARE THE BONE FOR A TOLERANCE RANGE FROM SLIGHT PRESSFIT TO SLIGHT CLEARANCE. BECAUSE THESE STEMS HAVE PROXIMAL TRABECULAR METAL COMBINED WITH A PROXIMAL TAPER THEY ACHIEVE ADEQUATE STABILITY THROUGH PROXIMAL FIXATION ALONE. IT HAS BEEN DETERMINED THAT DISTAL PRESS IS NOT REQUIRED AND THAT DISTAL PRESS COULD LEAD TO DIFFICULTY SEATING THE IMPLANT DEPENDANT ON BONE QUALITY, HUMERAL GEOMETRY, AND SURGEON REAMING. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE OCCURRENCE SUGGESTS THAT THE EVENT IS RELATED TO THE ISSUES FOR WHICH ZIMMER IS IMPLEMENTING CORRECTIVE ACTION. REFERENCE REMOVAL REPORT 1822565-7/26/2010-006-R FOR ADDITIONAL INFORMATION REGARDING THE CORRECTIVE ACTION TAKEN. DEVICE MEASUREMENTS MEET PRINTS SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.
EVALUATION SUMMARY: DURING TRABECULAR METAL HUMERAL AND THE TRABECULAR METAL REVERSE SHOULDER PROCEDURES, INSTRUMENTS PREPARE THE BONE FOR A TOLERANCE RANGE FROM SLIGHT PRESSFIT TO SLIGHT CLEARANCE. BECAUSE THESE STEMS HAVE PROXIMAL TRABECULAR METAL COMBINED WITH A PROXIMAL TAPER THEY ACHIEVE ADEQUATE STABILITY THROUGH PROXIMAL FIXATION ALONE. IT HAS BEEN DETERMINED THAT DISTAL PRESS IS NOT REQUIRED AND THAT DISTAL PRESS COULD LEAD TO DIFFICULTY SEATING THE IMPLANT DEPENDANT ON BONE QUALITY, HUMERAL GEOMETRY, AND SURGEON REAMING. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE OCCURRENCE SUGGESTS THAT THE EVENT IS RELATED TO THE ISSUES FOR WHICH ZIMMER IS IMPLEMENTING CORRECTIVE ACTION. REFERENCE REMOVAL REPORT 1822565-7/26/2010-006-R FOR ADDITIONAL INFORMATION REGARDING THE CORRECTIVE ACTION TAKEN. DEVICE MEASUREMENTS MEET PRINTS SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.
IT IS REPORTED THAT THE STEM BECAME INCARCERATED WHILE THE STEM WAS ONLY HALF WAY DOWN THE CANAL. THE STEM WAS REMOVED AND A SMALLER SIZE WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER TRABECULAR METAL HUMERAL STEM | SHOULDER PROSTHESIS | HSD | ZIMMER INC | NA | 60461894 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |