BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: CC E CC LIGHT FLAT PE HC LINER 28 / C

    MDR report key: 9863307 · Received March 21, 2020

    Report

    Report Number
    3005180920-2020-00173
    Event Type
    Injury
    Date Received
    March 21, 2020
    Date of Event
    February 25, 2020
    Report Date
    January 8, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807091
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY MEDACTA R&D DEPRTMENT: FROM THE RECEIVED PIECES, THE LINER SEEMED TO BE DEFORMED AND SLIGHTLY REDUCED IN DIMENSIONS. AS CONFIRMED BY THE ANALYSIS, THE DIMENSIONS ARE LOWER THAN SPECIFICATION, MOST PROBABLY DUE TO THE STERILIZATION IN HOSPITAL AND/OR DUE TO THE MEDACTA BIOWASHING. FROM THE RECEIVED PIECES AND INFORMATION, IT IS NOT POSSIBLE TO CLEARLY DETERMINE THE ROOT CAUSE OF THIS EVENT. VISUAL INSPECTION PERFORMED BY MEDACTA MEDICAL AFFAIRS DEPRTMENT: THE HEAD WAS FOUND TO BE FINELY SCRATCHED, IN A RATHER UNIFORM FASHION, ALMOST ALL OVER THE ENTIRE ARTICULATING SURFACE. THIS IS COMPATIBLE WITH ONE OR MULTIPLE HARD BODIES OF SMALL DIMENSIONS POSSIBLY TRAPPED IN THE ARTICULATION. IT IS NOT TO BE ASCRIBED TO THE REMOVAL PROCEDURE. OF NOTE, THE SCRATCHES ARE NUMEROUS BUT SHALLOW, COMPATIBLE WITH THE DAMAGES THAT CAN BE PROVOKED BY SEVERAL DEBRIS OF MEDIUM-HARDNESS MATERIAL. ADDITIONAL CLINIAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DEPRTMENT: THE NEW RADIOGRAPHS MADE AVAILABLE DID NOT CARRY ANY RELEVANT ADDITIONAL INFORMATION FOR THE CLINICAL EVALUATION.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 03 MARCH 2020. LOT 102331: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-SEP-2010. EXPIRATION DATE: 2015-08-31. 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: PARTIAL REVISION OF PRIMARY CEMENTLESS THA AFTER ALMOST 10 YEARS DUE TO PE WEAR ON A PATIENT WHO WAS (B)(6) YEARS OLD AT THE TIME OF INDEX SURGERY. THE ECCENTRICITY OF THE HEAD IS VISIBLE IN THE XRAY. HIGHLY CROSS-LINKED POLYETHYLENE WAS USED AND ONLY HEAD AND LINER HAVE BEEN REVISED. THIS WEAR RATE IS NOT TO BE CONSIDERED NORMAL FOR HIGHLY CROSS-LINKED POLYETHYLENE, UNLESS THE HEAD WAS SCRATCHED OR THIRD BODIES WERE TRAPPED IN THE ARTICULATION. NO COMMENT CAN BE OFFERED WITHOUT TECHNICAL ANALYSIS. ADDITIONAL IMPLANTS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 19 MARCH 2020. CUP: VERSAFITCUP CC 01.26.46MBTL ACETABULAR SHELL CC LIGHT Ø 46 LOT. 101043 (THIS ITEM IS NOT REGISTERED IN USA). LOT 101043: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JUN-2010. EXPIRATION DATE: 2015-05-31. 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. STEM: QUADRA-H 01.12.023 CEMENTLESS, HA COATED STD STEM SIZE 3 ((B)(4)) LOT. 100766. LOT 100766: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JUN-2010. EXPIRATION DATE: 2015-05-31. 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

    REVISION SURGERY PERFORMED 9 YEARS AND 4 MONTHS AFTER PRIMARY SURGERY, DUE TO ECCENTRICITY OF THE HEAD. IT WAS ALSO FOUND ACETABULAR AND PROXIMAL FEMUR OSTEOLYSIS. SUSPECTED LINER ABRASION. HEAD AND LINER SUCCESSFULLY REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327084 LINER: CC E CC LIGHT FLAT PE HC LINER 28 / C LINER FLAT PE LZO MEDACTA INTERNATIONAL SA 01.26.2839HCT 102331 07630030807091

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention