BIOMET REGENEREX PRIMARY TIBIAL TRAY 71 MM
Report
- Report Number
- 0001825034-2017-03455
- Event Type
- Injury
- Date Received
- May 26, 2017
- Date of Event
- July 12, 2017
- Report Date
- February 9, 2018
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- JWH
- PMA / PMN Number
- PK080361
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
(B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD TITANIUM PPS CLOSED BOX FEMORAL - RIGHT 62.5 MM, ITEM #: CP115732, LOT #: 837170. BIOMET FINNED PRIMARY STEM 80X15 MM, ITEM #: 141320, LOT #: 884540. VANGUARD PS+ TIBIAL BEARING 24X71/75 MM, ITEM #: 183754, LOT #: 486500. BIOMET REGENEREX 3 PEG SERIES A PATELLA, ITEM #: 141357, LOT #: 983930. BIOMET TIBIAL LOCKING BAR, ITEM #: 141205, LOT #: 984380. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT IS STILL 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: 0001825034-2017-03453, 0001825034-2017-03454, 0001825034-2017-03452, 0001825034-2017-03457 AND 0001825034-2017-03458.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION WAS PERFORMED. THE TIBIAL TRAY WAS ASSEMBLED WITH THE STEM. BONE INGROWTH CAN BE SEEN ON THE POROUS SURFACE OF THE TIBIAL, FEMORAL AND PATELLAR COMPONENTS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ALL THE METAL COMPONENTS THAT WERE IMPLANTED INTO THE PATIENT ARE MADE OF TI-6AL-4V ALLOY WHICH DOESN'T CONTAIN THE ABOVE-MENTIONED COMPONENTS WHICH THE PATIENT WAS ALLERGIC TO. THE COMPONENTS ARE PRESS-FIT AND NO BONE CEMENT WAS USED TO IMPLANT THE PRODUCT. THE ROOT CAUSE FOR THE RECURRING EFFUSIONS AND PAIN CANNOT BE DETERMINED. 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
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.
THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.
IT HAS BEEN REPORTED THAT FOLLOWING A REVISION OF THE TIBIAL BEARING, THE PATIENT CONTINUES TO EXPERIENCE EXTREME SWELLING IN HER KNEE. SHE BELIEVES SHE IS HAVING AN ALLERGIC REACTION TO THE DEVICES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
IT HAS BEEN REPORTED THAT FOLLOWING A REVISION OF THE TIBIAL BEARING, THE PATIENT CONTINUES TO EXPERIENCE EXTREME SWELLING IN HER KNEE. SHE BELIEVES SHE IS HAVING AN ALLERGIC REACTION TO THE DEVICES. ADDITIONAL INFORMATION RECEIVED INDICATED PATIENT IS SCHEDULED FOR A REVISION PROCEDURE.
IT IS FURTHER REPORTED THAT THE PATIENT WAS REVISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 375024 | BIOMET REGENEREX PRIMARY TIBIAL TRAY 71 MM | PROSTHESIS, KNEE | JWH | BIOMET ORTHOPEDICS | 770260 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention |