FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/13 MM R
MDR report key: 16866662
·
Received May 4, 2023
Report
- Report Number
- 3005180920-2023-00327
- Event Type
- Injury
- Date Received
- May 4, 2023
- Date of Event
- April 12, 2023
- Report Date
- May 4, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030862595
- PMA / PMN Number
- K140826
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 17 APRIL 2023: LOT 2000437: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAR-2020. EXPIRATION DATE: 2025-03-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.
Description of Event or Problem · 0
THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 2 YEARS FROM PRIMARY SURGERY THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 858997 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/13 MM R | KNEE TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 02.12.0313FR | 2000437 | 07630030862595 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |