FDA Adverse Event
Injury
Summary report: N
VNGD PS TIB BRG 10X71/75MM
MDR report key: 5908610
·
Received August 26, 2016
Report
- Report Number
- 0001825034-2016-03362
- Event Type
- Injury
- Date Received
- August 26, 2016
- Date of Event
- December 24, 2014
- Report Date
- February 24, 2017
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- JWH
- PMA / PMN Number
- PK023546
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
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. THIS REPORT IS NUMBER 2 OF 2 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-03361 / 03362). PRODUCT LOCATION UNKNOWN.
Additional Manufacturer Narrative · 1
THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CONCOMITANT MEDICAL PRODUCTS - FEMUR - CATALOGUE 183128 LOT 232800, TIBIAL TRAY - CATALOGUE 141514 LOT 831430, PATELLA - CATALOGUE 184784 LOT 306960.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY SIX MONTHS POST-IMPLANTATION DUE TO UNKNOWN REASONS. ALL COMPONENTS WERE REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 557484 | VNGD PS TIB BRG 10X71/75MM | PROSTHESIS, KNEE | JWH | BIOMET ORTHOPEDICS | N/A | 564920 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Hospitalization| R |