VNGD SSK PSC TIB BRG 14X71/75
Report
- Report Number
- 0001825034-2022-01597
- Event Type
- Injury
- Date Received
- July 12, 2022
- Date of Event
- June 16, 2022
- Report Date
- November 10, 2022
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- JWH
- UDI-DI
- 00880304440692
- PMA / PMN Number
- K042757
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-01592, 0001825034-2022-01593, 0001825034-2022-01594, 0001825034-2022-01595, 0001825034-2022-01596 AND 0001825034-2022-01598. MEDICAL DEVICES: BMT 360 TIB AUG 67X10MM CATALOG#: 185232 LOT#: 491370; BMT 360 TIB AUG 67X10MM CATALOG#: 185232 LOT#: 622080; BMT 360 TIB LG CRUCIATE WING CATALOG#: 185651 LOT#: 160950; BMT SPLINED KNEE STM V2 18X80 CATALOG#: 148308 LOT#: 710510; BMT 360 TIB TRAY 67MM CATALOG#: 185202 LOT#: 718090; VANGUARD CR ILOK FEM-RT 62.5 CATALOG#: 183006 LOT#: 846430. FOREIGN SOURCE: AUSTRALIA. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, D1, D4, D10, G3, G4, G6, H2, H4, AND H10. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-01592, 0001825034-2022-01593, 0001825034-2022-01594, 0001825034-2022-01595, 0001825034-2022-01596, 0001825034-2022-01597, 0001825034-2022-01598, 0001825034-2022-01917, 0001825034-2022-01918, AND 0001825034-2022-01919. D10 MEDICAL DEVICES: BMT 360 TIB AUG 71X10MM CATALOG#: 185233 LOT#: 970810, BMT 360 TIB AUG 71X10MM CATALOG#: 185233 LOT#: 956120, BMT 360 TIB LG CRUCIATE WING CATALOG#: 185651 LOT#: 805380, BMT SPLINED KNEE STM V2 18X40 CATALOG#: 148293 LOT#: 998960, BMT 360 TIB TRAY 71MM CATALOG#: 185203 LOT#: 502940, VNGD SSK 360 FEMUR L 67.5 CATALOG#: 185285 LOT#: 6668552, BMT 360 2.5MM OFFSET ADAPTER CATALOG#: 185210 LOT#: 136930, BMT SPLINED KNEE STM V2 18X40 CATALOG#: 148293 LOT#: 998960, BMT 360 2.5MM OFFSET ADAPTER CATALOG#: 185210 LOT#: 057070, SERIES A PAT THN 34 3 PEG CATALOG#: 184786 LOT#: 512610.
IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY TWENTY-TWO MONTHS POST IMPLANTATION DUE TO PAIN.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THE PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY TWENTY-TWO MONTHS POST IMPLANTATION DUE TO PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 701579 | VNGD SSK PSC TIB BRG 14X71/75 | PROSTHESIS, KNEE | JWH | ZIMMER BIOMET, INC. | N/A | 820100 | 00880304440692 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Hospitalization| R | SEE H10| SEE H10 |