BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR BALL HEAD 12/14 Ø 28 SIZE M 0

    MDR report key: 6837595 · Received September 1, 2017

    Report

    Report Number
    3005180920-2017-00485
    Event Type
    Injury
    Date Received
    September 1, 2017
    Date of Event
    August 4, 2017
    Report Date
    September 1, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805110
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SECOND REVISION SURGERY UNDERWENT BY THE PATIENT. PRIMARY SURGERY TOOK PLACE ON (B)(6) 2011. THE PATIENT DISLOCATED TWICE (LATE 2011/EARLY 2012), AND ON (B)(6) 2012 HE/SHE WAS REVISED TO A NON-MEDATCA, DM CUP AND A NEW LONGER MEDACTA HEAD. THEN, THE PATIENT CAME IN AGAIN AND THE SURGEON BOOKED ANOTHER REVISION SURGERY SINCE THE JOINT HAD 'LOCKED UP' AND THE GREATER TROCHANTER HAD FRACTURED. ON 18 AUGUST 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: TROCHANTERIC FRACTURE IN A (B)(6) CEMENTLESS THA, CONSISTING OF A MEDACTA STEM AND ANOTHER MANUFACTURER'S CUP. ACCORDING TO REPORT, THE JOINT "LOCKED UP" AND THE ABDUCTOR MUSCLES BROKE THE GREATER TROCHANTER, WEAKENED BY THE PRESENCE OF THE PROSTHETIC STEM. WE DO NOT KNOW WHAT CAUSED THE "LOCKING UP": THE USE OF ANOTHER COMPANY'S CUP HAD BEEN DECIDED BECAUSE THE PATIENT HAD RECURRENT DISLOCATIONS, THEREFORE THE ORIGINAL MEDACTA CUP WAS EXPLANTED AND SUBSTITUTED WITH A DOUBLE-MOBILITY SYSTEM AVAILABLE AT THE HOSPITAL. IT IS CONCEIVABLE, ALBEIT EXTREMELY UNUSUAL, THAT THE HYBRID COUPLING OF TWO COMPANIES PRODUCTS MAY HAVE CONTRIBUTED TO THE LOCKING UP, BUT AS EXPLANTS WERE DISCARDED WE CANNOT MEASURE THEM AND UNDERSTAND WHAT HAPPENED. THE CAUSE OF THE STEM REVISION IS A TROCHANTERIC FRACTURE; THE CAUSE OF THE LOCK UP IS UNKNOWN. BATCH REVIEW PERFORMED ON 28 AUGUST 2017. LOT 111572: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01 JULY 2011. EXPIRATION DATE: 2016-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO LIMITED RANGE OF MOTION AND GREATER TROCHANTER FRACTURE. THE FRACTURE WAS TREATED WITH THREE TROCHANTERIC PLATES IN ORDER TO FIX IT INTERNALLY. THE MEDACTA HEAD WAS REPLACED. THE INLAY WAS CHANGED AS WELL BUT IT WAS ANON- MEDACTA PRODUCT. THE SURGEON STATED THAT NO EXCESSIVE SIGNS OF WEAR OR DEBRIS WERE VISIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617264 COCR BALL HEAD 12/14 Ø 28 SIZE M 0 METALLIC BALL HEAD JDI MEDACTA INTERNATIONAL SA 111572 07630030805110

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention