FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R
MDR report key: 9676087
·
Received February 6, 2020
Report
- Report Number
- 3005180920-2020-00019
- Event Type
- Injury
- Date Received
- February 6, 2020
- Date of Event
- January 6, 2020
- Report Date
- February 6, 2020
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826146
- PMA / PMN Number
- K121416
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 07 JANUARY 2020. LOT 180423: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-APR-2018. EXPIRATION DATE: 2023-04-04. 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
A YEAR AND A HALF AFTER A SUCCESSFUL PRIMARY TOTAL KNEE, THE PATIENT COMPLAINT ON A ANTERIOR KNEE PAIN. THE SURGEON DECIDED TO RESURFACE THE PATELLA AND ACCORDING TO A LITTLE FLEXION LAXITY HE ALSO DECIDED TO REMOVE THE LINER AND TO CHANGE IT TO 12MM HEIGHT INSTEAD OF 10MM THAT WAS INSIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 139528 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R | TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 02.12.0210FR | 180423 | 07630030826146 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention |