FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/10 MM RIGHT
MDR report key: 6803619
·
Received August 18, 2017
Report
- Report Number
- 3005180920-2017-00455
- Event Type
- Injury
- Date Received
- August 18, 2017
- Date of Event
- July 19, 2017
- Report Date
- August 18, 2017
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826146
- PMA / PMN Number
- K121416
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 18 AUGUST 2017. LOT 140345: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 APRIL 2014. EXPIRATION DATE: 2019-02-28. NO ANOMALIES FOUND RELATED TO THE EVENT. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
THE PATIENT CAME IN COMPLAINING OF STIFFNESS. THE SURGEON REMOVED THE INSERT AND REMOVED SCAR TISSUE. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 583148 | GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/10 MM RIGHT | TIBIAL INSERT FIXED | JWH | MEDACTA INTERNATIONAL SA | 140345 | 07630030826146 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |