VERSYS FEMORAL BEADED FULLCOAT STEM
Report
- Report Number
- 1822565-2016-00809
- Event Type
- Injury
- Date Received
- April 1, 2016
- Date of Event
- May 27, 2014
- Report Date
- January 11, 2023
- Manufacturer
- ZIMMER INC
- Product Code
- LZO
- PMA / PMN Number
- K884952
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: VERSYS HEAD 0 X 28 DIA P/N 00801802802 L/N 60138389. THE FINAL REPORT WAS INCORRECTLY SUBMITTED UNDER 0001822565-2016-03166-2. REPORTED EVENT WAS CONFIRMED BY REVIEW OF XRAYS AND OP NOTES. DHR REVIEW INDICATES THE DEVICES WERE MANUFACTURED TO SPECIFICATIONS. THERE WERE NO ANOMALIES OR DEVIATIONS THAT WOULD HAVE AFFECTED THE SURGICAL OUTCOME OR CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED RELATED REPORT FOR THIS DEVICE FOR THE SAME OR A SIMILAR ISSUE. SECONDARY REVISION OP NOTES REPORTED REVISION FOR FRACTURED STEM THE PROXIMAL PORTION OF THE STEM WAS EASILY REMOVED, GIVEN THAT THIS WAS LOOSE. THERE WAS EXTENSIVE OSTEOLYSIS ABOUT THE PROXIMAL FEMUR. PREVIOUSLY ADDRESSED INVESTIGATION STATES THE CONTRIBUTING CONDITION SUCH AS HEAVY WEIGHT PATIENTS, IF THERE IS LACK PROXIMAL SUPPORT TO STEM, THE STEM IS VULNERABLE TO FATIGUE , DISTAL INGROWTH WITH INADEQUATE PROXIMAL GROWTH. STRESS SHIELDING, PROXIMAL LOOSENING MAY LEAD TO IMPLANT FRACTURE. WITH THE PROVIDED INFORMATION THE MOST LIKELY CAUSE OF THE ALLEGED EVENT IS THAT THE DISTAL INGROWTH AND INADEQUATE PROXIMAL GROWTH MAY LEAD TO BENDING FATIGUE OVER THE PAST 10 YEARS OF USE LEADING TO THE MID-STEM FRACTURE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A3; B4; B5; E1; E2; E3; G2; G3; H1; H2; H10 IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6: PROPOSED COMPONENT (ANNEX G) CODE IS MECHANICAL (G04) - STEM. NO PRODUCT WAS RETURNED FOR EVALUATION, HOWEVER THE PROVIDED PHOTOGRAPHS REVEAL THAT THE STEM WAS FRACTURED MEDIALLY AND INADEQUATE BONE GROWTH CAN BE SEEN FROM THE PROXIMAL PORTION OF THE STEM. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: AN INITIAL THA WAS PERFORMED ON AN UNKNOWN DATE, AND SUBSEQUENTLY THE FIRST REVISION OCCURRED ON (B)(6) 2004 WITH COMPETITOR PRODUCTS. DURING THIS REVISION IT WAS NOTED THERE WAS OSTEOLYSIS IN THE PROXIMAL FEMUR, AND UPON CONCLUSION ZB AND COMPETITOR PRODUCTS WERE PLACED. A SECOND REVISION OCCURRED ON (B)(6) 2014 DUE TO IMPLANT FRACTURE OF THE ZB STEM. THE PROXIMAL PORTION WAS EASILY REMOVED AS IT WAS LOOSE, AND EXTENSIVE OSTEOLYSIS WAS NOTED TO THE FEMUR. WEAR TO THE COMPETITOR LINER WAS INDICATED AS WELL. THE ZB HEAD AND STEM AND THE COMPETITOR LINER WERE REMOVED AND REPLACED. WITH THE PROVIDED INFORMATION THE MOST LIKELY CAUSE OF THE ALLEGED EVENT IS THAT THE DISTAL INGROWTH AND INADEQUATE PROXIMAL GROWTH MAY LEAD TO BENDING FATIGUE OVER THE PAST 10 YEARS OF USE LEADING TO THE MID-STEM FRACTURE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY ON UNKNOWN DATE WITH UNKNOWN PRODUCTS. THE PATIENT WAS REVISED AND ZIMMER BIOMET PRODUCTS WERE IMPLANTED. APPROXIMATELY 10 YEARS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO IMPLANT FRACTURE. DURING THE REVISION, THE PROXIMAL PORTION OF STEM REMOVED EASILY DUE TO LOOSENING AND EXTENSIVE OSTEOLYSIS. AN EXTRA 3 HOURS WAS NEEDED TO REVISE THE DISTAL PORTION OF THE STEM DUE TO BEING WELL FIXED. THE STEM, HEAD AND ACETABULAR LINER WERE EXCHANGED WITH COMPETITOR PRODUCTS.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
(B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
THIS INFORMATION WAS REPORTED IN ERROR ON INITIAL MDR #0001822565-2016-03166 ON 09-SEP-2016. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
IT IS REPORTED THE PATIENT WAS REVISED DUE TO A FRACTURED STEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 198025 | VERSYS FEMORAL BEADED FULLCOAT STEM | LZO | LZO | ZIMMER INC | 60129531 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male | Required Intervention | SEE H10. |