BIOMET 360 TIBIAL SM CRUCIATE WING
Report
- Report Number
- 0001825034-2021-03383
- Event Type
- Injury
- Date Received
- December 21, 2021
- Report Date
- April 13, 2022
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- JWH
- UDI-DI
- 00880304525771
- PMA / PMN Number
- K140883
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-03246, 0001825034-2021-03247, 0001825034-2021-03248, 0001825034-2021-03381, 0001825034-2021-03382, 0001825034-2021-03384, AND 0001825034-2021-03385. MEDICAL DEVICES: VANGUARD SSK 360 FEMUR L 67.5 CATALOG#: 185285 LOT#: 3800175; VANGUARD SSK PSC TIBIAL BEARING 12X71/75 CATALOG#: 183882 LOT#: 082250; BIOMET 360 TIBIAL TRAY 71MM CATALOG#: 185203 LOT#: 142500; VANGUARD 360 DISTAL FEMORAL AUGMENT 67.5X10 LL/R CATALOG#: 185405 LOT#: 607240; VANGUARD 360 DISTAL FEMORAL AUGMENT 67.5X5 RL/LM CATALOG#: 185305 LOT#: 726510; BIOMET SPLINED KNEE STEM V2 15X160 CATALOG#: 148329 LOT#: 836220; BIOMET SPLINED KNEE STEM V2 15X120 CATALOG#: 148318 LOT#: 698830. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED EVENT OF PAIN COULD NOT BE CONFIRMED AND THEREFORE THIS COMPLAINT CANNOT BE CONFIRMED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW FOUND INCREASED PAIN AND SWELLING AND ROM 0-110 DEGREES, NO INSTABILITY, NO COMPLICATIONS ON XRAY, SURGEON STATES INCREASED PAIN IS LIKELY DUE TO INCREASED ACTIVITY. NEXT FOLLOW UP FOUND WALKING WITH WALKER, NO REDNESS, MINIMAL SWELLING, ROM 0-110 DEGREES, NO INSTABILITY, CONTINUE WITH EXERCISES. ONE MONTH FOLLOW UP FOUND PATIENT WALKS WITH WALKER, MINIMAL SWELLING, ROM 0-110 DEGREES, MILD TO MODERATE SOFT TISSUE TENDERNESS OVER PES BURSA PROXIMAL TIBIA, NO COMPLICATIONS ON XRAY, DIAGNOSED WITH LOCAL HAMSTRING TENDONITIS / PES BURSITIS, GIVEN TOPICAL LIDODERM PATCH. PATIENT FELL STRAIGHT BACK TO DUE HER KNEE LOCKING UP. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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.
IT WAS REPORTED THAT PATIENT IS EXPERIENCING PAIN, SWELLING, LOSS OF RANGE OF MOTION, INSTABILITY, DIFFICULTY AMBULATING, AND FALLING DUE TO HER KNEE LOCKING UP APPROXIMATELY 18 MONTHS POST-IMPLANTATION. NO REVISION PROCEDURE HAS BEEN REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
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 |
|---|---|---|---|---|---|---|---|
| 1954144 | BIOMET 360 TIBIAL SM CRUCIATE WING | PROSTHESIS, KNEE | JWH | ZIMMER BIOMET, INC. | N/A | 017640 | 00880304525771 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Other | SEE H10 |