DUROM US ACET CMPNT 54/48 N
Report
- Report Number
- 0009613350-2023-00169
- Event Type
- Injury
- Date Received
- April 17, 2023
- Date of Event
- October 26, 2021
- Report Date
- October 12, 2023
- Manufacturer
- ZIMMER SWITZERLAND MANUFACTURING GMBH
- Product Code
- KWA
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A2, B4, B5, B7, D9, G3, G6, H1, H2, H6, 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.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. D-4 - INCORRECT UDI WAS PROVIDED IN REPORT 0009613350-2023-00169-2. UDI NOT AVAILABLE FOR ITEM# 01.00214.154. 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.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. D-10: METASUL LDH, HEAD, 48, CODE N, TAPER 18/20 ITEM#: 0100181480, LOT#: 2423608. LDH HEAD ADAPTER ITEM#: 01.000185.147, LOT#: 2345878. ML TAPER SZ12.5 EXT OFFSET ITEM#: 00-7711-012-20 LOT#: 60908663. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A REVIEW OF THE ADDITIONAL INFORMATION DOES NOT ALTER THE FINDINGS OF THE PREVIOUSLY REPORTED INVESTIGATION. 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.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. SURGICAL REPORT: ACCORDING TO THE RECEIVED SURGICAL REVISION SURGERY REPORT, THE REPORTED EVENT CAN BE CONFIRMED. THE RECEIVED MEDICAL DOCUMENTATION DID NOT CHANGE THE PREVIOUS INVESTIGATION SUMMARY. 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.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO EVALUATION OF THE X-RAYS AS THE REPORTED EVENT IS ALREADY KNOWN AND ADDRESSED IN WT123080. SURGICAL REPORT: NOT AVAILABLE FOR INVESTIGATION. NO PRODUCT WAS RETURNED FOR VISUAL EXAMINATION. THIS DEVICE IS INTENDED FOR TREATMENT. NO FURTHER INVESTIGATION REQUIRED AS THIS ISSUE IS KNOWN AND ADDRESSED IN WT123080 (ERROR PATTERN: POTENTIAL EARLY REVISION OF THE ACETABULAR COMPONENT DUE TO LOOSENING, IMPLANT MIGRATION OR UNRESOLVED PAIN, HIGHER ION RELEASE). MOST LIKELY ROOT CAUSE FOR THE REPORTED EVENT IS INAPPROPRIATE USE/IMPLANTATION OF THE PRODUCT. SHOULD ANY ADDITIONAL INFORMATION THAT CHANGES THE ASSESSMENT BECOME AVAILABLE TO US, OR ANY EXTRA DEMAND BE REQUESTED, WE WILL RE-EVALUATE THE CASE. 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.
(B)(4). D-10 UNKNOWN STEM ITEM# UNKNOWN LOT# UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
IT WAS REPORTED BY LEGAL THAT THE PATIENT UNDERWENT AN INITIAL RIGHT METAL-ON-METAL TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO PAIN, METALLOSIS, ELEVATED METAL ION LEVELS, AND DIFFICULTIES WITH DAILY LIVING, APPROXIMATELY THIRTEEN (13) YEARS LATER. DURING THE REVISION, AN ACTIVE ARTICULATION SYSTEM REPLACED THE METAL HEAD, AND THE SHELL AND STEM REMAINED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED BY LEGAL THAT THE PATIENT UNDERWENT AN INITIAL RIGHT METAL-ON-METAL TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO PAIN, METALLOSIS, ELEVATED METAL ION LEVELS, AND DIFFICULTIES WITH DAILY LIVING, APPROXIMATELY THIRTEEN (13) YEARS LATER. THE PATIENT ALSO DEVELOPED SEVERE CYSTIC LESIONS ABOVE THE CUP. DURING THE REVISION, THE SHELL AND STEM WERE FOUND TO BE STABLE AND WELL-FIXED AND WERE LEFT INTACT. A NEW ACTIVE ARTICULATION HEAD AND LINER WERE PLACED. BONE MATRIX WAS APPLIED TO A DRILL HOLE MADE WITHIN THE ACETABULUM. THE REVISION WAS COMPLETED WITHOUT COMPLICATIONS OR FURTHER SIGNIFICANT FINDINGS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT HIP REVISION DUE TO LOOSENING OF ACETABULAR CUP, PAIN AND METALLOSIS, APPROXIMATELY THIRTEEN (13) YEARS FROM INITIAL IMPLANTATION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2318887 | DUROM US ACET CMPNT 54/48 N | HIP PROTHESIS | KWA | ZIMMER SWITZERLAND MANUFACTURING GMBH | N/A | 2418286 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Hospitalization| R | SEE H10 NARRATIVE.| SEE H10 NARRATIVE. |