FDA Adverse Event
Injury
Summary report: N
STAR TOTAL ANKLE REPLACEMENT
MDR report key: 2896398
·
Received December 28, 2012
Report
- Report Number
- 3003640913-2012-00042
- Event Type
- Injury
- Date Received
- December 28, 2012
- Date of Event
- December 11, 2012
- Report Date
- December 28, 2012
- Manufacturer
- WALDEMAR LINK, GMBH & CO.
- Product Code
- HSN
- PMA / PMN Number
- P050050
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SLIDING CORE BEARING REVISED AFTER BEING IMPLANTED FOR 10 YEARS. VISUAL EVALUATION SHOWS FRACTURED SLIDING CORE BEARING. REVIEW OF DEVICE HISTORY RECORDS SHOWS NO ANOMALIES.
Description of Event or Problem · 1
PATIENT HAD STAR SLIDING CORE BEARING REVISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STAR TOTAL ANKLE REPLACEMENT | STAR SLIDING CORE | HSN | WALDEMAR LINK, GMBH & CO. | 400-140 | 0119054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |