EVOLIS 3031.0003 CEMENTLESS TIBIAL BASEPLATE SIZE 3
Report
- Report Number
- 3005180920-2023-01028
- Event Type
- Injury
- Date Received
- December 22, 2023
- Date of Event
- November 27, 2023
- Report Date
- March 8, 2024
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- PMA / PMN Number
- K081023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
ON FEBRUARY 23RD 2024 WE HAVE RECEIVED THE PIECES INVOLVED IN THE EVENT. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER. THE POST OF THE TIBIAL INSERT LOOKS DAMAGED IN THE ANTERIOR PART; THIS WAS PROBABLY BECAUSE OF THE CONTACT WITH THE FEMORAL COMPONENT IN CORRESPONDENCE OF THE INTERCONDYLAR NOTCH WITH THE KNEE IN EXTENSION. FROM VISUAL INSPECTION, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO A FAULTY DEVICE. IN ADDITION WE HAVE RECEIVED THE INFORMATION OF OTHER ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON (B)(6) 2024: EVOLIS 3050.0024 INSET PATELLA 24MM (K081023) LOT. 040628. LOT 040628: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JUN-2004. EXPIRATION DATE: 2009-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. EVOLIS 3060.3012 STEM LENGTH 30MM Ø12MM (K081023) LOT. 060094. LOT 060094: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-03-2006. EXPIRATION DATE: 2011-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. CORRECTIONS: 1- CONSIDERING THE ITEMS INVOLVED IN THE COMPLAINT WE RECOGNISED THE SALES ARE TO BE UPDATED, BATCH REVIEW PERFORMED ON (B)(6) 2024. EVOLIS 3031.0003 CEMENTLESS TIBIAL BASEPLATE SIZE 3 (K081023) LOT. 042025. LOT 042025: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-MAY-2005. EXPIRATION DATE: 2010-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. EVOLIS 3042.0309 POSTERO STABILIZED INSERT 9MM SIZE 3 (K081023) LOT. 050189. LOT 050189: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JUL-2005. EXPIRATION DATE: 2010-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF TEH REVIEW. EVOLIS 3012.003D CEMENTLESS POSTERO STABILIZED FEMUR RIGHT SIZE 3 (K081023) LOT. 041309 LOT 041309: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2004. EXPIRATION DATE: 2009-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. 2- THE E1 INITIAL REPORTER (B)(6) DA MEDACTA US A MEDACTA FR.
CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: LATE SECONDARY INFECTION SEVERAL YEARS (PRIMARY DATE UNSPECIFIED) AFTER CEMENTLESS TKA IN AN ELDERLY WOMAN. ALL IMPLANTS HAVE BEEN REPLACED AND INFECTION TREATED WITH A ONE-STEP EXCHANGE PROCEDURE. NO REASON TO SUSPECT FAULTY IMPLANTS AT THE ORIGIN OF THIS ADVERSE EVENT. PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER: REVISION SURGERY OF AN EVOLIS CEMENTLESS IMPLANT AFTER 5 YEARS FROM PRIMARY FOR INFECTION. FROM PRELIMINARY INVESTIGATION BASED ON THE PICTURES OF THE REMOVED COMPONENTS, NO ANOMALIES CAN BE IDENTIFIED. FROM INVESTIGATION THERE IS NO REASON TO SUSPECT THAT THE EVENT IS RELATED TO A FAULTY DEVICE. NEW INFORMATION/CORRECTION REPORTED IN THIS FOLLOW-UP: CLINICAL EVALUATION, PRELIMINARY INVESTIGATION, THE DEVICES ARE AVAILABLE, BUT NOT RECEIVED YET (FIELD "DEVICES EVALUATED BY MANUFACTURER"), DESCRIPTION OF THE EVENT UPDATED.
BATCH REVIEW PERFORMED ON 21-DEC-2023. LOT 042025: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-MAY-2005. EXPIRATION DATE: 2010-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAS BEEN SOLD. OTHER DEVICES INVOLVED: EVOLIS 3042.0309 POSTERO STABILIZED INSERT 9MM SIZE 3 (K081023) LOT 050189: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JUL-2005. EXPIRATION DATE: 2010-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF TEH REVIEW. EVOLIS 3012.003D CEMENTLESS POSTERO STABILIZED FEMUR RIGHT SIZE 3 (K081023) LOT 041309:(B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2004. EXPIRATION DATE: 2009-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEM OF LOT HAS BEEN SOLD.
THE PRIMARY SURGERY WAS PERFORMED IN 1997 WITH IMPLANTS NOT FROM MEDACTA. IN AN UNKNOWN YEAR AND WITH AN UNKNOWN REASON THE IMPLANTS WERE REVISED TO MEDACTA COMPONENTS. IN 2019 A WASHOUT WAS PERFORMED WITHOUT REVISING ANY IMPLANT. CURRENTLY, THE PATIENT UNDERWENT REVISION SURGERY DUE TO STREPTOCOCCUS INFECTION. ALL IMPLANTS WERE REVISED.
THE PATIENT HAS BEEN REVISED FOLLOWING STREPTOCOCCUS INFECTION. MOREOVER, IT HAS BEEN REPORTED THAT THE PATIENT HAD AN IMPLANT WASH 5 YEARS AGO WITHOUT REVISION OF THE IMPLANTS AT THAT TIME. NO INFORMATION ARE AVAILABLE ABOUT THE PRIMARY SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1325356 | EVOLIS 3031.0003 CEMENTLESS TIBIAL BASEPLATE SIZE 3 | KNEE CEMENTLESS TIBIAL BASEPLATE | JWH | MEDACTA INTERNATIONAL SA | 042025 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Female | Required Intervention |