FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/12 MM L
MDR report key: 12786105
·
Received November 10, 2021
Report
- Report Number
- 3005180920-2021-00870
- Event Type
- Injury
- Date Received
- November 10, 2021
- Date of Event
- October 12, 2021
- Report Date
- November 10, 2021
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826979
- PMA / PMN Number
- K121416
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 15 OCTOBER 2021: LOT 140336: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-APR-2014. EXPIRATION DATE: 2019-MAR-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 0
THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 3 YEARS AND 9 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1689896 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/12 MM L | TIBIAL INSERT FIXED SPHERE FLEX | JWH | MEDACTA INTERNATIONAL SA | 02.12.0612FL | 140336 | 07630030826979 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |