FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L
MDR report key: 9085922
·
Received September 19, 2019
Report
- Report Number
- 3005180920-2019-00776
- Event Type
- Injury
- Date Received
- September 19, 2019
- Date of Event
- August 21, 2019
- Report Date
- September 19, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826535
- PMA / PMN Number
- K121416
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 2 SEPTEMBER 2019: LOT 180394: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-APR-2018. EXPIRATION DATE: 2023-04-12. NO ANOMALIES FOUND IN THE BATCH. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR EVENT REPORTED.
Description of Event or Problem · 1
ABOUT 1 YEAR AND 1 MONTH AFTER PRIMARY REVISION SURGERY FOR KNEE PAIN. THE REASON OF PAIN IS UNKNOWN. INSERT SWAP PERFORMED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 884896 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L | TIBIAL INSERT FIXED | JWH | MEDACTA INTERNATIONAL SA | 180394 | 07630030826535 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |