FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM L
MDR report key: 13280395
·
Received January 18, 2022
Report
- Report Number
- 3005180920-2022-00027
- Event Type
- Injury
- Date Received
- January 18, 2022
- Date of Event
- December 21, 2021
- Report Date
- January 18, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030862526
- PMA / PMN Number
- K140826
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 24 DECEMBER 2021: LOT 181885: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUN-2018. EXPIRATION DATE: 2023-05-29. NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT SIMILAR REPORTED EVENTS.
Description of Event or Problem · 0
THE PATIENT CAME IN 1 MONTH AND HALF AFTER THE PRIMARY SURGERY REPORTING INSTABILITY DUE TO LAXITY. THE SURGEON REVISED THE 11MM POLY WITH A 17MM POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 850038 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM L | KNEE TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 02.12.0211FL | 181885 | 07630030862526 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Female | Required Intervention |