FDA Adverse Event
Injury
Summary report: N
E1 VANGUARD PS TIBIAL BEARING 71/75X10
MDR report key: 3950531
·
Received July 22, 2014
Report
- Report Number
- 0001825034-2014-06356
- Event Type
- Injury
- Date Received
- July 22, 2014
- Report Date
- July 28, 2014
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- JWH
- PMA / PMN Number
- PK080528
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.
Additional Manufacturer Narrative · 1
EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DURING THE EVALUATION, IT WAS NOTED THE PITTING MARKS AND WEARING PATTERNS SHOWN ON THE COMPONENTS ARE MOST LIKELY THE RESULT OF THIRD BODY WEAR BETWEEN THE ARTICULATING SURFACES.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO WEAR OF THE POLYETHYLENE TIBIAL BEARING. THE TIBIAL BEARING AND TIBIAL TRAY WERE REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 428224 | E1 VANGUARD PS TIBIAL BEARING 71/75X10 | PROSTHESIS, KNEE | JWH | BIOMET ORTHOPEDICS | N/A | 231700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |