FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L
MDR report key: 9207000
·
Received October 18, 2019
Report
- Report Number
- 3005180920-2019-00881
- Event Type
- Injury
- Date Received
- October 18, 2019
- Date of Event
- September 19, 2019
- Report Date
- October 18, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826733
- 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 25 SEPTEMBER 2019. LOT 1811461: 75 ITEMS MANUFACTURED AND RELEASED ON 19-MAR-2019. EXPIRATION DATE: 2024-03-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 50 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
REVISION SURGERY PERFORMED AFTER 24 DAYS FROM THE PRIMARY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN WASHOUT AND REVISED THE LINER SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1003092 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L | KNEE TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 1811461 | 07630030826733 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |