FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/10 MM R
MDR report key: 12777612
·
Received November 9, 2021
Report
- Report Number
- 3005180920-2021-00869
- Event Type
- Injury
- Date Received
- November 9, 2021
- Date of Event
- October 12, 2021
- Report Date
- November 9, 2021
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826740
- 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 21 OCTOBER 2021: LOT 2000450: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAR-2020. EXPIRATION DATE: 2025-02-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 0
THE PATIENT CAME IN REPORTING PAIN AND TIGHTNESS IN THE KNEE DUE TO SCAR TISSUE THAT HAD DEVELOPED. AT 4 MONTHS FROM PRIMARY THE SURGEON CLEANED OUT THE SCAR TISSUE AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1679354 | GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/10 MM R | TIBIAL INSERT FIXED | JWH | MEDACTA INTERNATIONAL SA | 02.12.0510FR | 2000450 | 07630030826740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |