FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L
MDR report key: 13504672
·
Received February 10, 2022
Report
- Report Number
- 3005180920-2022-00112
- Event Type
- Injury
- Date Received
- February 10, 2022
- Date of Event
- January 19, 2022
- Report Date
- February 10, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826610
- 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 (B)(6) 2022: LOT 1811459: (B)(4)ITEMS MANUFACTURED AND RELEASED ON 29-MAR-2019. EXPIRATION DATE: 2024-03-18. 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 INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. AT 2 YEARS AND 3 MONTHS FROM THE PRIMARY THE SURGEON REVISED THE INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY. IMPLANTED INSERT: 02.12.0417FL GMK-SPHERE TIBIAL INSERT - FLEX S4L - 17MM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 257874 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L | KNEE FIXED TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 02.12.0414FL | 1811459 | 07630030826610 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |