FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L
MDR report key: 8260588
·
Received January 18, 2019
Report
- Report Number
- 3005180920-2018-01107
- Event Type
- Injury
- Date Received
- January 18, 2019
- Date of Event
- December 26, 2018
- Report Date
- January 18, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826139
- PMA / PMN Number
- K121416
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 17 JANUARY 2019. LOT 171039: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 MAY 2017. EXPIRATION DATE: 2022-04-26 NO ANOMALIES FOUND RELATED TO THE PROBLEM. 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 PAIN, 15 MONTHS AFTER PRIMARY SURGERY. THE SURGEON RESURFACED THE PATELLA AND PERFORMED A POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 54510 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L | TIBIAL INSERT FIXED | JWH | MEDACTA INTERNATIONAL SA | 171039 | 07630030826139 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |