FDA Adverse Event
Injury
Summary report: N
GMK TIBIAL TRAY FIXED CEMENTED SIZE 3 LEFT
MDR report key: 2870014
·
Received December 6, 2012
Report
- Report Number
- 3005180920-2012-00084
- Event Type
- Injury
- Date Received
- December 6, 2012
- Date of Event
- November 5, 2012
- Report Date
- December 6, 2012
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- PMA / PMN Number
- K090988
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DOCUMENT REVIEW: GMK PRIMARY CEMENTED FIXED TIBIAL TRAY SIZE 3 LEFT: (B)(4) / LOT 111462 ((B)(4) ITEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDING WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. (B)(4) ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. THE SURGERY PLAN WAS VERIFIED AS MY KNEE CUTTING BLOCKS WERE USED ((B)(4)): IT SEEMS THAT THERE WAS A SURGERY MISTAKE DURING THE TIBIAL CUT THAT IS HIGHLY LIKELY THE REASON OF THE MALPOSITIONING. ON THE BASIS OF THE DATA COLLECTED, A DEVICE INVOLVEMENT IN THE EVENT OCCURRED IS HIGHLY UNLIKELY.
Description of Event or Problem · 1
THE TIBIAL INSERT WAS REPLACED DUE TO MIS-ALIGNED VALGUS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GMK TIBIAL TRAY FIXED CEMENTED SIZE 3 LEFT | KNEE TIBIAL COMPONENT | JWH | MEDACTA INTERNATIONAL SA | 111462 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |