FDA Adverse Event
Injury
Summary report: N
STAR TOTAL ANKLE REPLACEMENT
MDR report key: 2840565
·
Received October 24, 2012
Report
- Report Number
- 3003640913-2012-00034
- Event Type
- Injury
- Date Received
- October 24, 2012
- Date of Event
- September 20, 2012
- Report Date
- October 24, 2012
- Manufacturer
- WALDEMAR LINK, GMBH & CO
- Product Code
- HSN
- PMA / PMN Number
- P050050
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADD'L MODEL #: 400-255. ADD'L LOT #: 990610, 00308. PRODUCT IMPLANTED FOR 10 YRS. STAR TOTAL ANKLE WAS EXPLANTED, AND A CEMENT SPACER WAS PUT IN PLACE TO FUSE ANKLE AT A LATER DATE. REVIEW OF MFG RECORDS SHOWED NO ANOMALIES.
Description of Event or Problem · 1
PT HAD THE STAR TOTAL ANKLE EXPLANTED. CEMENT SPACER WAS PUT IN PLACE TO FUSE ANKLE AT A LATER DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STAR TOTAL ANKLE REPLACEMENT | STAR SLIDING CORE | HSN | WALDEMAR LINK, GMBH & CO | 400-141 | 119013 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |