FDA Adverse Event
Injury
Summary report: N
GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 1/10MM
MDR report key: 5812217
·
Received July 21, 2016
Report
- Report Number
- 3005180920-2016-00374
- Event Type
- Injury
- Date Received
- July 21, 2016
- Date of Event
- June 23, 2016
- Report Date
- July 21, 2016
- 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
BATCH REVIEW PERFORMED ON 18 JULY 2016. LOT 110882: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 JUNE 2011. EXPIRATION DATE: 2016-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. NOT AVAILABLE.
Description of Event or Problem · 1
THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE KNEE WAS LOOSE. THE SURGEON REVISED THE 10MM INSERT AND REVISED WITH A 14MM INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 466906 | GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 1/10MM | TIBIAL INSERT FIXED | JWH | MEDACTA INTERNATIONAL SA | 110882 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |