BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR BALL HEAD 12/14 Ø 32 SIZE L +3.5

    MDR report key: 6057218 · Received October 26, 2016

    Report

    Report Number
    3005180920-2016-00541
    Event Type
    Injury
    Date Received
    October 26, 2016
    Date of Event
    September 26, 2016
    Report Date
    November 29, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 21 OCTOBER 2016 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: AFTER THE FIRST REVISION, HAPPENED 3 YEARS AGO, THE MEDACTA PRODUCT LEFT IS THE ACETABULAR CUP. THIS OPERATION DID NOT INVOLVE THE CUP, EXCEPT FOR THE ROUTINE EXCHANGE OF THE INSERT, WHICH IS ALWAYS DONE WHEN THE JOINT IS OPENED. THEREFORE, THERE IS NO ANALYSIS RELEVANT TO THE PERFORMANCE OF THE MEDACTA PRODUCT INVOLVED, BECAUSE THE CUP IS STILL WELL FIXED AND WELL PERFORMING, AND IT HAS OBVIOUSLY NO ROLE IN THE PROBLEM DUE TO TROCHANTERIC MALUNION. BATCH REVIEWS PERFORMED ON 26 OCTOBER 2016. LOT 114025: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 JANUARY 2012. EXPIRATION DATE: 2016-11-30. 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. HOODED PE HC FIXED LINER DIAM 32 / E, CODE 01.26.3244HCAT, LOT. 130087 (K103352) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 MARCH 2013. EXPIRATION DATE: 2018-01-31. 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. ON 26 OCTOBER 2016 THE (B)(4) PROJECT MANAGER ANALYSED THE RETURNED IMPLANTS AND COMMENTED AS FOLLOWS: OBSERVING THE METALLIC FEMORAL HEAD, THE EXTERNAL SURFACE IS PARTICULARLY SCRATCHED, PROBABLY DUE TO REPEATED CONTACTS BETWEEN THE HEAD AND THE SHELL. OBSERVING THE LINER, THE EXTERNAL POLAR SURFACE DOES NOT HAVE ANY PARTICULAR SIGN. THIS PORTION OF THE LINER IS SLIGTHLY YELLOW, PROPABLY DUE TO LIPID ABSORPTION. THE EXTERNAL CONICAL SURFACE DOES NOT HAVE ANY PARTICULAR SIGN, EXCEPT NEAR THE SHOULDER WHERE IT IS DAMAGED AND FRACTURED, PROBABLY BECAUSE OF THE REMOVAL PHASE. THE INTERNAL SURFACE DOES NOT HAVE ANY PARTICULAR SIGN. IT IS NOT POSSIBLE FROM THE INSPECTION OF THE IMPLANTS DETERMINE THE ROOT CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON 30 OCTOBER 2016 AND INCLUDES: THE PATIENT HAD A FRACTURE OF THE FEMUR YEARS AGO. DUE TO THIS, THE TROCHANTER MAIOR WAS LOOSENED TO THE OTHER PART OF THE FEMUR AND ROTATED FREELY AROUND THE FEMUR BONE. IN FLEXION THE TROCHANTER MAIOR IMPINGED WITH THE ILIAC CREST AND DUE TO THIS THE HIP LUXATED IN POSTERIOR DIRECTION. THE SURGEON DECIDED TO EXPLANT THE INLAY OF THE VERSAFITCUP AND CEMENTED A SMALLER INLAY IN ANTEVERSION INTO THE CUP IN ORDER TO AVOID ANOTHER POSTERIOR LUXATION.

    Description of Event or Problem · 1

    REVISION SURGERY REQUIRED DUE TO LUXATION OF THE HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710245 COCR BALL HEAD 12/14 Ø 32 SIZE L +3.5 METALLIC BALL HEAD JDI MEDACTA INTERNATIONAL SA 114025

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention