OSS POLY TIBIAL BUSHING
Report
- Report Number
- 0001822565-2023-00973
- Event Type
- Injury
- Date Received
- April 11, 2023
- Date of Event
- September 21, 2022
- Report Date
- October 3, 2025
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- JDI
- UDI-DI
- 00880304002258
- PMA / PMN Number
- K002757
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. X-RAY REVIEW BY THIRD PARTY HCP STATES THAT THERE IS COMPLETE DISLOCATION OF A LEFT TOTAL KNEE ARTHROPLASTY. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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). CONCOMITANT MEDICAL PRODUCT(S): 150410 - OSS TIBIAL POLY BEARING 12MM - 050720; 150493 - OSS REINFORCED YOKE - 826110; 150478 - OSS POLY LOCK PIN - 530340; 150480 - OSS AXLE - 632970. REPORT SOURCE, FOREIGN COUNTRY: JAPAN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT WAS DISCARDED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-00787; 0001822565-2023-00972.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A4; B4; B5; B7; D2; G1; G3; G6; H1; H2. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G1; G3; G6; H1; H2; H3. THE EVENT IS CONFIRMED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL. THE NOTES STATE THAT THERE WAS EXCESSIVE INTERNAL ROTATION OF THE TIBIAL IMPLANT THOUGHT TO BE THE SOURCE OF THE PATELLA DISLOCATION. THE PATIENT WAS REPORTED TO HAVE A FALL WITHOUT THE BRACE. THERE WAS ANTERIOR DISPLACEMENT OF FEMORAL IMPLANT AND OPEN DISLOCATION OF KNEE JOINT AND NATURAL PATELLA WAS FOUND TO BE DISLOCATED. ROOT CAUSE REMAINS UNCHANGED. 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 TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THEY SUFFERED A FALL AND UNDERWENT A REVISION SURGERY APPROXIMATELY 2 MONTHS LATER DUE TO IMPLANT DISLOCATION. THE ARTICULAR SURFACE AND HINGE WERE REPLACED. IT IS UNKNOWN WHEN AND HOW THE PATIENT FELL. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A LEFT KNEE OSS SYSTEM. SUBSEQUENTLY, THE PATIENT'S PATELLA CONTINUED TO DISLOCATE LATERALLY. AN ADJUSTMENT PROCEDURE WAS PERFORMED AS WELL AS A REMOVAL OF LATERAL PATELLAR RETINACULUM AND IMPLANTATION OF EXTENSION KNEE BRACE. APPROXIMATELY 15 DAYS AFTER THE ADJUSTMENT, THE LEFT KNEE GAVE AWAY WHILE THE PATIENT WAS NOT WEARING KNEE BRACE AND THE PATIENT FELL RESULTING IN AN OPEN DISLOCATION. THE PATIENT WAS SUBSEQUENTLY REVISED WHERE THE FINAL INSERT WAS PLACED. DURING THE REVISION, A PARTIAL DETACHMENT OF VASTUS LATERALIS WAS FOUND AND AN EXPLORATION OF THE LATERAL PATELLAR RETINACULUM WAS PERFORMED WITH IMPROVEMENT TO STABILITY OF THE PATELLA. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 397086 | OSS POLY TIBIAL BUSHING | PROSTHESIS, KNEE | JDI | ZIMMER BIOMET, INC. | N/A | 724780 | 00880304002258 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Male | Required Intervention| H | SEE H10. |