FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM R
MDR report key: 8045563
·
Received November 7, 2018
Report
- Report Number
- 3005180920-2018-00864
- Event Type
- Injury
- Date Received
- November 7, 2018
- Date of Event
- October 9, 2018
- Report Date
- November 7, 2018
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826825
- 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 06 NOVEMBER 2018. LOT 180416: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 APRIL 2018. EXPIRATION DATE: 04/04/2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEM 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. THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND SWAPPED THE POLY 2 WEEKS AFTER PRIMARY SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 887627 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM R | KNEE TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 180416 | 07630030826825 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |