FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM R
MDR report key: 18701122
·
Received February 14, 2024
Report
- Report Number
- 3005180920-2024-00059
- Event Type
- Injury
- Date Received
- February 14, 2024
- Date of Event
- January 18, 2024
- Report Date
- February 14, 2024
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826788
- 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 01 FEBRUARY 2024: LOT 2204111: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-MAY-2022. EXPIRATION DATE: 2027-05-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE,(B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
REVISION DUE TO INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 11 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 52686 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM R | KNEE TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 2204111 | 07630030826788 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |