FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM R E-CROSS
MDR report key: 20106840
·
Received August 30, 2024
Report
- Report Number
- 3005180920-2024-00676
- Event Type
- Injury
- Date Received
- August 30, 2024
- Date of Event
- July 31, 2024
- Report Date
- August 30, 2024
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- PMA / PMN Number
- K202022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 07 AUG 2024: LOT 2215913: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-AUG-2022. EXPIRATION DATE: 2027-08-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
AT 11 MONTHS FROM HTE PRIMARY, THE PATIENT CAME IN REPORTING KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE POLY (FROM 11 TO 14 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1802732 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM R E-CROSS | KNEE TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 2215913 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |