FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 4/12 MM R
MDR report key: 14751777
·
Received June 21, 2022
Report
- Report Number
- 3005180920-2022-00484
- Event Type
- Injury
- Date Received
- June 21, 2022
- Date of Event
- May 26, 2022
- Report Date
- June 21, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630971261822
- PMA / PMN Number
- K202022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 02 JUNE 2022. LOT 2112626: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2021. EXPIRATION DATE: (B)(6) 2026. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ONLY THE ITEM INVOLVED IN THIS COMPLAINT HAS BEEN SOLD.
Description of Event or Problem · 0
AT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 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 |
|---|---|---|---|---|---|---|---|
| 1261322 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 4/12 MM R | KNEE FIXED TIBIAL INSERT PE | JWH | MEDACTA INTERNATIONAL SA | 02.12.E0412CRR | 2112626 | 07630971261822 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |