FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM L
MDR report key: 9834573
·
Received March 16, 2020
Report
- Report Number
- 3005180920-2020-00170
- Event Type
- Injury
- Date Received
- March 16, 2020
- Date of Event
- February 21, 2020
- Report Date
- March 16, 2020
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030862601
- PMA / PMN Number
- K140826
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 04-MAR-2020: LOT 180924: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2018. EXPIRATION DATE: 13.05.2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 1 YEAR AND 2 MONTHS AFTER THE PRIMARY, THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 299660 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM L | KNEE FIXED TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 02.12.0411FL | 180924 | 07630030862601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |