FDA Adverse Event
Injury
Summary report: N
TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L
MDR report key: 7600575
·
Received June 14, 2018
Report
- Report Number
- 3005180920-2018-00421
- Event Type
- Injury
- Date Received
- June 14, 2018
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826337
- PMA / PMN Number
- K121416
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 12 JUNE 2018: LOT 160595: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 MAY 2016. EXPIRATION DATE: 2021-04-27 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
ABOUT 2 YEARS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR KNEE INSTABILITY AND ANTERIOR KNEE PAIN. INLAY SWAP AND PATELLA RESURFACING. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 444378 | TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L | TIBIAL INSERT FIXED | JWH | MEDACTA INTERNATIONAL SA | 160595 | 07630030826337 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |