FDA Adverse Event
Injury
Summary report: N
GMK-SPHERIKA 02.12.E0413FR TIBIAL INSERT FIXED SPHERE FLEX SIZ4/13 MM R E-CROSS
MDR report key: 18382645
·
Received December 22, 2023
Report
- Report Number
- 3005180920-2023-00978
- Event Type
- Injury
- Date Received
- December 22, 2023
- Date of Event
- November 28, 2023
- Report Date
- December 22, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630971261884
- 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 06-DEC-2023. LOT 2201765: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-APR-2022. EXPIRATION DATE: 2027-03-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED CASE DURING THE PERIOD OF THE REVIEW.
Description of Event or Problem · 0
THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2023. SUBSEQUENTLY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. ON (B)(6) 2023, THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT. PRESENTLY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2051516 | GMK-SPHERIKA 02.12.E0413FR TIBIAL INSERT FIXED SPHERE FLEX SIZ4/13 MM R E-CROSS | KNEE TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 2201765 | 07630971261884 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |