FDA Adverse Event
Injury
Summary report: N
STAR TOTAL ANKLE REPLACEMENT
MDR report key: 2122131
·
Received June 3, 2011
Report
- Report Number
- 3003640913-2011-00010
- Event Type
- Injury
- Date Received
- June 3, 2011
- Date of Event
- March 9, 2011
- Report Date
- June 3, 2011
- Manufacturer
- WALDEMAR LINK, GMBH & CO
- Product Code
- HSN
- PMA / PMN Number
- P050050
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
COMPONENTS WERE NOT RETURNED FOR EVALUATION. IMAGES OF POLY CORE CONFIRMED WEAR IN ACTIVE PT. REVIEW OF MANUFACTURING RECORDS SHOWED NO ANOMALIES.
Description of Event or Problem · 1
TOTAL ANKLE IMPLANT WAS REVISED TO A FUSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STAR TOTAL ANKLE REPLACEMENT | ANKLE PROSTHESIS | HSN | WALDEMAR LINK, GMBH & CO | 400-142 | 0121043 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |