FDA Adverse Event
Injury
Summary report: N
GMK FIXED POSTERO STABILIZED TIBIAL INSERT
MDR report key: 3573300
·
Received November 22, 2013
Report
- Report Number
- 3005180920-2013-00150
- Event Type
- Injury
- Date Received
- November 22, 2013
- Date of Event
- October 23, 2013
- Report Date
- November 22, 2013
- Manufacturer
- MEDACTA INTERNATIONAL, SA
- Product Code
- JWH
- PMA / PMN Number
- K090988
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DOCUMENT REVIEW: GMK PRIMARY FIXED PS TIBIAL INSERT SIZE 5 THICKNESS 10. CODE (B)(4)/LOT 111390 ((B)(4) ITEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. TWENTY-FOUR ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. ON THE BASIS OF THE DATA COLLECTED, WE HAVE NO EVIDENCES THAT THE PROBLEM IS DEVICE RELATED.
Description of Event or Problem · 1
REFERENCE IMP # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 610591 | GMK FIXED POSTERO STABILIZED TIBIAL INSERT | PE TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL, SA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |