FDA Adverse Event
Injury
Summary report: N
TIBIAL INSERT FIXED SPHERE FLEX #5/13 MM R
MDR report key: 7380660
·
Received March 29, 2018
Report
- Report Number
- 3005180920-2018-00188
- Event Type
- Injury
- Date Received
- March 29, 2018
- Date of Event
- February 27, 2018
- Report Date
- March 29, 2018
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030862670
- PMA / PMN Number
- K140826
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON (B)(6) 2018, LOT 141425: (B)(6) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2014, EXPIRATION DATE: 03/21/2019. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH A SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
EIGHTEEN DAYS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A KNEE INFECTION. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 224585 | TIBIAL INSERT FIXED SPHERE FLEX #5/13 MM R | TIBIAL INSERT FIXED | JWH | MEDACTA INTERNATIONAL SA | 141425 | 07630030862670 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |