FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/13 MM R
MDR report key: 14485259
·
Received May 24, 2022
Report
- Report Number
- 3005180920-2022-00396
- Event Type
- Injury
- Date Received
- May 24, 2022
- Date of Event
- April 27, 2022
- Report Date
- May 24, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030862717
- PMA / PMN Number
- K140826
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 28 APRIL 2022. LOT 1902510: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUN-2019. EXPIRATION DATE: 2024-05-14. 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 · 0
THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY 1 YEAR AND 6 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1676520 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/13 MM R | KNEE TIBIAL INSERT PE | JWH | MEDACTA INTERNATIONAL SA | 02.12.0613FR | 1902510 | 07630030862717 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |