OSS RS 12MM LS TIBIAL BEARING
Report
- Report Number
- 0001825034-2023-01779
- Event Type
- Injury
- Date Received
- August 3, 2023
- Date of Event
- July 10, 2023
- Report Date
- November 19, 2024
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- KRO
- UDI-DI
- 00880304467989
- PMA / PMN Number
- K021260
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). D10: 150476 - OSS POLY TIBIAL BUSHING - 364410. 161034 - OSS RS POLY FEM BUSHINGS SET/2 - 659600. 150478 - OSS POLY LOCK PIN - 833270. 161035 - OSS RS AXLE - 168370. 150493 - OSS REINFORCD YOKE - 584150. 150427 - OSS TIB BLK AUG 10X71/75 UNIV - 385370. 150427 - OSS TIB BLK AUG 10X71/75 UNIV - 126010. 150400 - OSS POROUS IM STEM 21.5 X 150 - 795170. 161041 - OSS RS NON-MOD PLT LONG 71 - 942080R. 161014 - OSS RS 8.5CM ELLIP SEG FMRL-LT - 419750. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001825034-2023-01780, 0001825034-2023-01781, 0001825034-2023-01782, 0001825034-2023-01783, AND 0001825034-2023-01784.
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. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED EXPLANTED AXLE, YOKE, BUSHINGS AND BEARING. THE POLYETHYLENE BEARING IS WORN UNEVENLY. THE BUSHINGS AND THE BEARING ALSO SHOW SIGNS OF DAMAGE AND FRACTURE. IT IS ASSUMED TO BE CAUSED BY THE EXPLANATION OF THE DEVICES BUT UNKNOWN. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: POLYETHYLENE WEAR, TWO RADIO-OPAQUE OBJECTS ARE NOTED NOT CONNECTED TO THE IMPLANTS, BONE QUALITY IS OSTEOPENIC, NO EVIDENCE OF IMPLANT LOOSENING. LATERAL POLYETHYLENE WEAR WITH VALGUS MALALIGNMENT AS NOTED. THIS COULD RESULT IN PAIN/INSTABILITY. 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.
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; H6 VISUAL INSPECTION OF THE PHOTOGRAPH PROVIDED CONFIRMS THAT THE BEARING, TIBIAL BUSHINGS AND THE YOKE TABS HAVE FRACTURED. REVISION NOTES PROVIDED STATE THAT POLYETHYLENE INSERT WAS NOTED TO BE BROKEN AND RESTING ANTERIOR TO THE DISTAL FEMORAL PIECE. FRAGMENTS OF POLYETHYLENE FOUND SCARRED INTO MEDIAL CAPSULE AND WERE RETRIEVED WITH X-RAY AND THE REMAINING BUSHINGS AND MODULAR PIECES WERE EXPLANTED. FEMUR AND TIBIA SOLIDLY FIXED AND IN APPROPRIATE POSITION. 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.
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY. SUBSEQUENTLY, THE PATIENT PRESENTED WITH LEFT KNEE PAIN AND INSTABILITY APPROXIMATELY FIVE YEARS POSTOP AND UNDERWENT A REVISION SURGERY. THE BEARING AND BUSHING KIT WERE REVISED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
IT WAS FURTHER REPORTED THAT THE PATIENT REPORTED CLUNKING, INSTABILITY, AND PAIN AND WAS REVISED. DURING THE REVISION, THE POLY INSERT WAS NOTED TO BE BROKEN. NO INTRAOPERATIVE COMPLICATIONS REPORTED. FROM PROVIDED IMAGES, THE YOKE AND TIBIAL BUSHING WERE ALSO FRACTURED. 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 |
|---|---|---|---|---|---|---|---|
| 281070 | OSS RS 12MM LS TIBIAL BEARING | PROSTHESIS, KNEE | KRO | ZIMMER BIOMET, INC. | N/A | 068590 | 00880304467989 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention| H | SEE H10... |