FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R
MDR report key: 19603259
·
Received June 25, 2024
Report
- Report Number
- 3005180920-2024-00445
- Event Type
- Injury
- Date Received
- June 25, 2024
- Date of Event
- May 23, 2024
- Report Date
- June 25, 2024
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826146
- 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 04 JUNE 2024: LOT 172805: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-JUL-2017. EXPIRATION DATE: 2022-06-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 6 YEARS AND 7 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 |
|---|---|---|---|---|---|---|---|
| 1103514 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R | KNEE INSERT FIXED | JWH | MEDACTA INTERNATIONAL SA | 172805 | 07630030826146 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Female | Required Intervention |