FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM L
MDR report key: 15273673
·
Received August 23, 2022
Report
- Report Number
- 3005180920-2022-00634
- Event Type
- Injury
- Date Received
- August 23, 2022
- Date of Event
- July 24, 2022
- Report Date
- August 23, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826573
- 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 04 AUGUST 2022. LOT 180925: 25 ITEMS MANUFACTURED AND RELEASED ON 29-MAY-2018. EXPIRATION DATE: 2023-05-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 22 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
AT ABOUT 6 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND DUE TO SIGNS OF AN INFECTION. THE REASON FOR THE INSTABILITY AND PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE GMK-SPHERE TIBIAL INSERT (12 MM TO 13MM TO IMPROVE THE STABILITY KNEE IN PER-OP). THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2102193 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM L | KNEE TIBIAL INSERT PE | JWH | MEDACTA INTERNATIONAL SA | 02.12.0412FL | 180925 | 07630030826573 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |