FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM L
MDR report key: 18054069
·
Received November 2, 2023
Report
- Report Number
- 3005180920-2023-00838
- Event Type
- Injury
- Date Received
- November 2, 2023
- Date of Event
- September 28, 2023
- Report Date
- November 2, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826375
- PMA / PMN Number
- K121416
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 06 OCTOBER 2023: LOT 170292: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-APR-2017. EXPIRATION DATE: 2022-04-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.
Description of Event or Problem · 0
REVISION SURGERY DUE TO INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 6 YEARS AND 1 MONTH 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 |
|---|---|---|---|---|---|---|---|
| 215411 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM L | KNEE TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 170292 | 07630030826375 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |