FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/10 MM R
MDR report key: 15679059
·
Received October 27, 2022
Report
- Report Number
- 3005180920-2022-00831
- Event Type
- Injury
- Date Received
- October 27, 2022
- Date of Event
- October 14, 2022
- Report Date
- October 27, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826948
- 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 18-OCT-2022: LOT 2002808: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JUN-2020. EXPIRATION DATE: 2025-06-01. 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 YEAR AND 9 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE INSERT (10 MM) WITH A THICKER ONE (12MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2942749 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/10 MM R | KNEE TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 02.12.0610FR | 2002808 | 07630030826948 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |