FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/17 MM L
MDR report key: 18038496
·
Received October 31, 2023
Report
- Report Number
- 3005180920-2023-00852
- Event Type
- Injury
- Date Received
- October 31, 2023
- Date of Event
- October 3, 2023
- Report Date
- October 31, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826658
- PMA / PMN Number
- K121416
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 12 OCTOBER 2023: LOT 140328: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MARCH-2014. EXPIRATION DATE: 2019-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
AT ABOUT 6 YEARS 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER (17 TO 20 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1981106 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/17 MM L | KNEE TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 140328 | 07630030826658 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Female | Required Intervention |