FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX #6/10 MM R
MDR report key: 13152886
·
Received January 4, 2022
Report
- Report Number
- 3005180920-2022-00006
- Event Type
- Injury
- Date Received
- January 4, 2022
- Date of Event
- December 13, 2021
- Report Date
- January 4, 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 20.12.2021. LOT 1904568: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JUL-2019. EXPIRATION DATE: 2024-JUL-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 0
THE PATIENT CAME IN 1 YEAR AND 4 MONTHS AFTER THE PRIMARY SURGERY REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE INSERT (10MM TO 12MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 513756 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX #6/10 MM R | KNEE TIBIAL INSERT FIXED | JWH | MEDACTA INTERNATIONAL SA | 02.12.0610FR | 1904568 | 07630030826948 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |