FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L
MDR report key: 13236220
·
Received January 12, 2022
Report
- Report Number
- 3005180920-2022-00007
- Event Type
- Injury
- Date Received
- January 12, 2022
- Date of Event
- December 13, 2021
- Report Date
- January 12, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826733
- PMA / PMN Number
- K121416
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 17 DECEMBER 2021: LOT 2011308: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-JAN-2021. EXPIRATION DATE: 2025-12-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 0
REVISION SURGERY PERFORMED AT ABOUT 1 MONTH AFTER PRIMARY DUE TO INFECTION. THE LINER WAS SWAPPED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1331505 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L | TIBIAL INSERT FIXED | JWH | MEDACTA INTERNATIONAL SA | 02.12.0510FL | 2011308 | 07630030826733 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |