FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/17 MM R
MDR report key: 13280939
·
Received January 18, 2022
Report
- Report Number
- 3005180920-2022-00025
- Event Type
- Injury
- Date Received
- January 18, 2022
- Date of Event
- December 21, 2021
- Report Date
- January 18, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826665
- PMA / PMN Number
- K121416
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 27 DECEMBER 2021. LOT 183062: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUNE-2018. EXPIRATION DATE: 2023-JUN-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 0
AT 1 MONTH AND 12 DAYS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 122677 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/17 MM R | KNEE TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 02.12.0417FR | 183062 | 07630030826665 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |