FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE 02.12.0310FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L
MDR report key: 14051932
·
Received April 8, 2022
Report
- Report Number
- 3005180920-2022-00244
- Event Type
- Injury
- Date Received
- April 8, 2022
- Date of Event
- March 11, 2022
- Report Date
- April 8, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826337
- 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 14 MARCH 2022 LOT 142492: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JUN-2014. EXPIRATION DATE: 2019-04-30. 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 SINCE 2018.
Description of Event or Problem · 0
THE PATIENT CAME IN REPORTING PAIN AND POST-OP X-RAYS SHOWED THAT THE SCREW BACKED OUT FROM THE POLY. THE SURGEON REMOVED THE SCREW AND REVISED THE POLY 6 YEARS AND 10 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF THE SURGEON USED A TORQUE-LIMITING SCREWDRIVER DURING THE PRIMARY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 161584 | GMK-SPHERE 02.12.0310FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L | TIBIAL INSERT FIXED | JWH | MEDACTA INTERNATIONAL SA | 02.12.0310FL | 142492 | 07630030826337 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |