FDA Adverse Event
Injury
Summary report: N
OXF ANATOMIC BRG RT X-SM 5MM
MDR report key: 3796924
·
Received May 7, 2014
Report
- Report Number
- 0001825034-2014-03637
- Event Type
- Injury
- Date Received
- May 7, 2014
- Date of Event
- January 3, 2014
- Report Date
- March 3, 2016
- Manufacturer
- BIOMET U.K. LTD
- Product Code
- NRA
- PMA / PMN Number
- PP010014
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECT PRODUCT IDENTIFICATION.
Additional Manufacturer Narrative · 1
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS IT STATES, "INSTABILITY".
Additional Manufacturer Narrative · 1
THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT INFORMATION. DISCARDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO INSTABILITY. THE BEARING WAS REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 276298 | OXF ANATOMIC BRG RT X-SM 5MM | PROSTHESIS, KNEE | NRA | BIOMET U.K. LTD | N/A | 2679470 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Hospitalization| R |