FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX #3/12 MM L
MDR report key: 7706389
·
Received July 20, 2018
Report
- Report Number
- 3005180920-2018-00525
- Event Type
- Injury
- Date Received
- July 20, 2018
- Date of Event
- June 21, 2018
- Report Date
- July 20, 2018
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826375
- PMA / PMN Number
- K121416
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 17 JULY 2018. LOT 162159: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 JULY 2016 EXPIRATION DATE: 2021-06-19; 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 DUE TO SIGNS OF INFECTION 2 MONTHS AFTER PRIMARY. THE WBC COUNT WAS HIGH YET CULTURES CAME BACK NEGATIVE. THE SURGEON PERFORMED AN I&D AND SWAPPED THE POLY FOR PREVENTATIVE PURPOSES. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 548739 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX #3/12 MM L | TIBIAL INSERT FIXED | JWH | MEDACTA INTERNATIONAL SA | 162159 | 07630030826375 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |