FDA Adverse Event
Injury
Summary report: N
TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/17 MM R
MDR report key: 8089810
·
Received November 20, 2018
Report
- Report Number
- 3005180920-2018-00938
- Event Type
- Injury
- Date Received
- November 20, 2018
- Date of Event
- October 24, 2018
- Report Date
- November 20, 2018
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826269
- 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 20 NOVEMBER 2018: LOT 163066: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-AUG-2016. EXPIRATION DATE: 2021-07-26. 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
THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 1 WEEK AFTER THE PRIMARY. THE PATHOGEN IS UNKNOWN AT THIS TIME. THE SURGEON PERFORMED AN I&D AND POLYSWAP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 928303 | TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/17 MM R | KNEE TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 163066 | 07630030826269 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |