FDA Adverse Event
Injury
Summary report: N
VANGRD ANT STBLZD BRG 10X71
MDR report key: 4251114
·
Received November 14, 2014
Report
- Report Number
- 0001825034-2014-08560
- Event Type
- Injury
- Date Received
- November 14, 2014
- Date of Event
- October 22, 2014
- Report Date
- December 15, 2014
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- MBH
- PMA / PMN Number
- PK050222
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: ¿POSTOPERATIVE PAIN.¿
Additional Manufacturer Narrative · 1
EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. A DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED DUE TO THE DAMAGE ON THE BEARING.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO PAIN AND INSTABILITY. REVIEW OF RADIOGRAPHS REVEALED A FRACTURED LOCKING BAR. THE TIBIAL BEARING AND LOCKING BAR WERE REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 738642 | VANGRD ANT STBLZD BRG 10X71 | PROSTHESIS, KNEE | MBH | BIOMET ORTHOPEDICS | N/A | 735070 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |