OXF TRL BRG W/SLOTS MED 3MM
Report
- Report Number
- 3002806535-2022-00426
- Event Type
- Malfunction
- Date Received
- October 18, 2022
- Date of Event
- September 20, 2022
- Report Date
- January 17, 2023
- Manufacturer
- BIOMET UK LTD.
- Product Code
- NRA
- UDI-DI
- 05019279346813
- PMA / PMN Number
- P010014
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). FOREIGN - (B)(6). INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THAT ON THE BOTTOM OF THE TRIAL BEARING THERE ARE TWO LARGE FRACTURES EITHER SIDE WITH MISSING PIECES WHERE THE SLOT FOR THE HANDLE IS MACHINED. THERE IS ONE OF THE MISSING FRAGMENTS IS SHOWN IN THE PHOTO BUT THE OTHER IS NOT PRESENT. THE ITEM HAS SCORE MARKS AND DINGS AND DENTS CONSISTENT WITH MULTIPLE USAGE. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS; LOT IDENTIFICATION WAS NOT PROVIDED. DEVICE IS USED FOR TREATMENT. MEDICAL RECORDS WERE NOT PROVIDED. 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.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THAT THERE ARE TWO LARGE FRACTURES ON THE BOTTOM SURFACE. THE FRACTURES ARE ON BOTH SIDES WHERE THE SLOT FOR THE HANDLE IS MACHINED. THE TRIAL BEARING HAS SCORE MARKS AND DINGS AND DENTS CONSISTENT WITH MULTIPLE USAGE. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. DEVICES IS USED FOR TREATMENT. MEDICAL RECORDS WERE NOT PROVIDED. 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 DURING THE SURGERY WHEN THE SURGEON WAS TRIALING, THE BEARING TRIAL CHIPPED. NO PIECES FELT IN PATIENT. NO HARM REPORTED. 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.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2482896 | OXF TRL BRG W/SLOTS MED 3MM | KNEE INSTRUMENT | NRA | BIOMET UK LTD. | N/A | ZB6682990 | 05019279346813 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Prefer Not To Disclose |