FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 2/12 MM R
MDR report key: 14267125
·
Received May 3, 2022
Report
- Report Number
- 3005180920-2022-00340
- Event Type
- Injury
- Date Received
- May 3, 2022
- Date of Event
- April 7, 2022
- Report Date
- May 2, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630971261341
- PMA / PMN Number
- K202022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 12-APRIL-2022. LOT 2112606: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-DEC-2021. EXPIRATION DATE: 2026-NOV-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT.
Description of Event or Problem · 0
THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 25 DAYS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1317469 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 2/12 MM R | FIXED TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 02.12.E0212CRR | 2112606 | 07630971261341 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |