FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/17 MM L
MDR report key: 13470946
·
Received February 7, 2022
Report
- Report Number
- 3005180920-2022-00071
- Event Type
- Injury
- Date Received
- February 7, 2022
- Date of Event
- January 10, 2022
- Report Date
- February 7, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826658
- 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-FEB-2022: LOT 2100107: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-MAR-2021. EXPIRATION DATE: 2026-03-07. NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 0
PRESENTLY, ON 10 JANUARY 2022, AT 12 DAYS AFTER THE PREVIOUS REVISION, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION, THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY, THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 487237 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/17 MM L | KNEE TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 02.12.0417FL | 2100107 | 07630030826658 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |