FDA Adverse Event
Injury
Summary report: N
STAR TOTAL ANKLE REPLACEMENT
MDR report key: 1751224
·
Received July 7, 2010
Report
- Report Number
- 3003640913-2010-00022
- Event Type
- Injury
- Date Received
- July 7, 2010
- Date of Event
- March 22, 2010
- Report Date
- July 7, 2010
- Manufacturer
- WELDEMAR LINK & GMBH & CO.
- Product Code
- NTG
- PMA / PMN Number
- P050050
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- KS, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
TIBIAL AND TALAR COMPONENTS SHOWED SOME MARKS ASSUMED TO BE FROM EXPLANT. POLY SHOWED NORMAL WEAR.
Description of Event or Problem · 1
PT HAD STAR COMPONENTS REMOVED AND REPLACED DUE TO ANTERIOR TALAR AND ANTERIOR TIBIAL SUBSIDENCE 10 YEARS AFTER INITIAL IMPLANT. TALAR COMPONENT # 400-256, LOT # 070597/153. TIBIAL COMPONENT # 400-263, LOT # 120399/121. POLY COMPONENT # 400-142.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STAR TOTAL ANKLE REPLACEMENT | STAR TOTAL ANKLE | NTG | WELDEMAR LINK & GMBH & CO. | 400-256 | 070597/153 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention | ACHILLES LENGTHENING |