FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX #3/11 MM R
MDR report key: 16655291
·
Received March 31, 2023
Report
- Report Number
- 3005180920-2023-00224
- Event Type
- Injury
- Date Received
- March 31, 2023
- Date of Event
- March 3, 2023
- Report Date
- March 31, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030862588
- PMA / PMN Number
- K140826
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 15-MAR-2023 LOT 1902497: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUN-2019. EXPIRATION DATE: 2024-05-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
AT ABOUT 6 MONTHS AFTER THE PRIMARY, REVISON SURGERY PERFORMED DUE TO INFECTION. THE INSERT WAS REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 505870 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX #3/11 MM R | KNEE TIBIAL INSERT FIXED | JWH | MEDACTA INTERNATIONAL SA | 02.12.0311FR | 1902497 | 07630030862588 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Female | Required Intervention |