FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L
MDR report key: 17649307
·
Received August 30, 2023
Report
- Report Number
- 3005180920-2023-00667
- Event Type
- Injury
- Date Received
- August 30, 2023
- Date of Event
- August 2, 2023
- Report Date
- August 30, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826535
- PMA / PMN Number
- K121416
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 09-AUG-2023. LOT 2214103: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-AUG-2022. EXPIRATION DATE: 2027-07-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 23 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
AT 5 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISE THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1680141 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L | KNEE TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 2214103 | 07630030826535 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |