FDA Adverse Event
Injury
Summary report: N
EVOLIS TIBIAL BASE PLATE TI PLASMA SPRAYED
MDR report key: 2096621
·
Received March 31, 2011
Report
- Report Number
- 3005180920-2011-00015
- Event Type
- Injury
- Date Received
- March 31, 2011
- Date of Event
- March 8, 2011
- Report Date
- March 31, 2011
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- PMA / PMN Number
- K081023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE ANALYSIS OF THE THREE BATCH RECORDS WERE DONE AND NO ANOMALIES WERE FOUND CONCERNING THE PROBLEM OCCURRED. EVOLIS TI PLASMA SPRAYED BASEPLATE IN THE USA IS CLEARED UNDER K081023 (EVOLIS TOTAL KNEE SYSTEM) AS CEMENTED PROSTHESIS, BUT THE SURGEON IMPLANTED IT WITHOUT CEMENT. IN THE IFU AND SURGICAL TECHNIQUE FOR U.S OF EVOLIS, IT CLEARLY INDICATED THAT THE PRODUCT IS TO BE CEMENTED. WITHOUT USING CEMENT, IT IS KNOWN THAT THE RISK OF LOOSENING IS HIGHER THAN CEMENTED SYSTEMS. THE EVENT IS NOT DEVICE RELATED, BUT DUE TO A USER ERROR.
Description of Event or Problem · 1
THE MOBILIZATION OF THE IMPLANTS FEMUR AND TIBIA COMPONENTS REQUIRED A REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EVOLIS TIBIAL BASE PLATE TI PLASMA SPRAYED | TIBIAL BASE PLATE | JWH | MEDACTA INTERNATIONAL SA | 083022 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention | EVOLIS TIBIAL INSERT: REF. (B)(4), LOT. 090722| EVOLIS TI PLASMA SPRAYED BASPLATE:| REF. (B)(4), LOT. 083022| EVOLIS TI PLASMA SPRAYED FEMUR COMPONENT:| REF. (B)(4), LOT. 090741| LOT. 090722| EVOLIS FEMUR TI PLASMA SPRAYED:| REF. (B)(4), LOT. 090741| EVOLIS TIBIAL INSERT: REF. (B)(4) |