FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R
MDR report key: 16466504
·
Received March 2, 2023
Report
- Report Number
- 3005180920-2023-00107
- Event Type
- Injury
- Date Received
- March 2, 2023
- Date of Event
- January 31, 2023
- Report Date
- March 2, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826382
- PMA / PMN Number
- K121416
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 07 FEBRUARY 2023: LOT 2001729: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-APR-2020. EXPIRATION DATE: 2025-03-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.
Description of Event or Problem · 0
AT ABOUT 2 YEARS FROM PRIMARY THE SURGEON REVISED THE PATIENT LINER FOR KNEE INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 454150 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R | TIBIAL INSERT FIXED | JWH | MEDACTA INTERNATIONAL SA | 02.12.0312FR | 2001729 | 07630030826382 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |