FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R
MDR report key: 15575843
·
Received October 11, 2022
Report
- Report Number
- 3005180920-2022-00771
- Event Type
- Injury
- Date Received
- October 11, 2022
- Date of Event
- September 16, 2022
- Report Date
- October 10, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826184
- 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 22 SEPTEMBER 2022 LOT#: 2000428, 60 ITEMS MANUFACTURED AND RELEASED ON 13-MAR-2020. EXPIRATION DATE: 2025-FEB-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. AT ABOUT 1 YEAR AND 5 MONTHS, THE SURGEON REVISED THE INSERT WITH A HIGHER ONE (FROM 12 TO 13 MM), AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2801615 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R | TIBIAL INSERT FIXED | JWH | MEDACTA INTERNATIONAL SA | 02.12.0212FR | 2000428 | 07630030826184 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |