OSS TIBIAL POLY BEARING 12MM
Report
- Report Number
- 0001825034-2019-05260
- Event Type
- Injury
- Date Received
- November 18, 2019
- Date of Event
- December 12, 2019
- Report Date
- February 12, 2020
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- JDI
- PMA / PMN Number
- K002757
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. CORRECTED: D4. UPDATED: D4; H4.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED PRODUCTS IDENTIFIED THAT THE TIBIAL BEARING FRACTURED INTO MULTIPLE PIECES (2 LARGE PIECES, OTHER SMALL PIECES, NOT ALL RETURNED) AND THE TIBIAL BUSHING IS FRACTURED (NOT ALL PIECES RETURNED). RETURNED PRODUCTS WERE SUBMITTED FOR FURTHER ANALYSIS. ANALYSIS DETERMINED THAT THE TIBIAL BEARING IS FRACTURED AND HAS SIGNS OF WEAR. THE WEAR WAS CAUSED BY RUBBING/GRINDING AGAINST THE TIBIAL PLATE, POSSIBLY DUE TO OVERLOADING WHILE IN FULL EXTENSION OR HYPEREXTENSION. THE FRACTURE WAS POTENTIALLY CAUSED BY GRADUAL PENETRATION OF THE YOKE INTO THE BEARING MATERIAL DUE TO PULLING FORCES IN EXTENSION FOLLOWED BY SUBSEQUENT FRACTURE DUE TO POTENTIAL OVERLOADING OF THE REDUCED BEARING MATERIAL AND POSSIBLY EXACERBATED BY RELATIVE MOTION OF THE IMPLANT COMPONENTS AFTER THE YOKE PENETRATION. THE TIBIAL BUSHING IS FRACTURED/ CRACKED POSSIBLY DUE TO ASYMMETRICAL OVERLOADING. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THAT THE LOCK PIN IS FRACTURED, WITH ONLY ONE PIECES PHOTOGRAPHED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED HYPEREXTENSION OF THE RIGHT KNEE, WITH SOFT TISSUE SWELLING AND JOINT EFFUSION. BONE QUALITY APPEARS MILDLY OSTEOPENIC. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY FOUR YEARS POST IMPLANTATION DUE TO HYPEREXTENSION WITH HARD METAL STOP OF THE PROSTHESIS, DUE TO POSSIBLE MALFUNCTION OF THE COUPLING MECHANISM. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
(B)(4). IMPLANT DATE: 2015. CONCOMITANT MEDICAL PRODUCTS: 150356 449990 OSS 7CM SEG ELLIPT FEMORAL RT, 150393 852780 OSS POROUS IM STEM 14.5 X 150, 150448 146530 OSS POR STRAIGHT STEM 10.5X150, 150443 719450 OSS MOD PROX TIB 9CM M, 150493 097220 OSS REINFORCED YOKE. REPORT SOURCE: FOREIGN COUNTRY: (B)(6). 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. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. 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: 0001825034-2019- 05259.
IT WAS REPORTED PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED HYPEREXTENSION WITH HARD METAL STOP OF THE PROSTHESIS, APPROXIMATELY FOUR YEARS POST IMPLANTATION, DUE TO POSSIBLE MALFUNCTION OF THE COUPLING MECHANISM. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1130518 | OSS TIBIAL POLY BEARING 12MM | PROSTHESIS, KNEE | JDI | ZIMMER BIOMET, INC. | N/A | 822780 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Hospitalization| R |