FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM L
MDR report key: 17570816
·
Received August 18, 2023
Report
- Report Number
- 3005180920-2023-00647
- Event Type
- Injury
- Date Received
- August 18, 2023
- Date of Event
- July 30, 2023
- Report Date
- August 18, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030862601
- PMA / PMN Number
- K140826
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 03-AUG-2023 LOT 2246143: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-MAR-2023. EXPIRATION DATE: 2028-02-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
AT ABOUT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED SUCCESSFULLY THE LINER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2166575 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM L | TIBIAL INSERT FIXED | JWH | MEDACTA INTERNATIONAL SA | 2246143 | 07630030862601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Female | Required Intervention |