OPTIPAC 60 REFOB BONE CMT R-3
Report
- Report Number
- 3006946279-2024-00082
- Event Type
- Injury
- Date Received
- November 25, 2024
- Date of Event
- May 30, 2024
- Report Date
- January 7, 2025
- Manufacturer
- BIOMET FRANCE S.A.R.L.
- Product Code
- MBB
- UDI-DI
- 04040029922361
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D10, G3, G6, H1, H2, H11. D10 - MEDICAL PRODUCTS REF 150480 LOT 66097344 OSS AXLE REF 150493 LOT 66077093 OSS YOKE 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.
(B)(4). D10 - MEDICAL PRODUCTS: OSS TIBIAL POLY BEARING 12MM CATALOG # 150410 LOT # 65790754, OSS TIB BLK AUG 10X63/67 UNIV CATALOG # 150426 LOT # 66008034, OSS TIB BLK AUG 10X79/83 UNIV CATALOG # 150428 LOT # 696020, OSS NON-MOD TIB PLATE LONG 63 CATALOG # 150419 LOT # 66153805, OSS POLY TIBIAL BUSHING CATALOG # 150476 LOT # 65733841. G2: BELGIUM. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H1, H2, H3, H6, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. HOWEVER, IMAGES ARE NOT PERTINENT TO CURRENT COMPLAINT. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE REVIEW IDENTIFIED A REVISION - RIGHT TOTAL KNEE ARTHROPLASTY FOR RECURRENT DISLOCATION OF OSS-TYPE HINGED KNEE PROSTHESIS. IMPLANT WAS EASILY REMOVED WITHOUT BONE DAMAGE OF THE TIBIAL IMPLANT. TIBIAL REPLACEMENTS CEMENTED WITHOUT COMPLICATION. IT WAS IMPOSSIBLE TO RELEASE THE EXTENSOR APPARATUS IN ORDER TO BE ABLE TO CLOSE THE ARTHROTOMY. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CAN BE CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT 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.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY TWO MONTHS POST INITIAL RIGHT KNEE HINGED SALVAGE SYSTEM IMPLANTATION DUE TO RECURRENT DISLOCATION. THE TIBIAL COMPONENTS WERE REVISED WHILE THE FEMORAL COMPONENTS REMAINED INTACT. IT WAS NOT POSSIBLE TO RELEASE THE EXTENSOR APPARATUS TO CLOSE THE ARTHROTOMY, THEREFORE, A SUBCUTANEOUS CLOSURE WAS PERFORMED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1707361 | OPTIPAC 60 REFOB BONE CMT R-3 | BONE CEMENT, ANTIBIOTIC | MBB | BIOMET FRANCE S.A.R.L. | N/A | AW29BE0809 | 04040029922361 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| H | SEE H11 NARRATIVE. |