BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR LINERS

    MDR report key: 9457640 · Received December 12, 2019

    Report

    Report Number
    1818910-2019-122635
    Event Type
    Injury
    Date Received
    December 12, 2019
    Report Date
    November 19, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: NO DEVICE WAS RECEIVED. ROOT CAUSE UNDETERMINED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. (B)(4).

    Description of Event or Problem · 1

    LITERATURE ARTICLE ENTITLED, ¿CONSIDERATIONS REGARDING POLYETHYLENE WEAR IN TOTAL HIP ARTHROPLASTY¿ BY H. FAHANDEZH-SADDI DÍAZ, PUBLISHED BY ORTHOPAEDIC TRAUMATOLOGY (2003), VOL. 47, PP. 175-181, WAS REVIEWED. THE PURPOSE OF THIS ARTICLE IS TO REPORT THE RESULTS OF REVISION SURGERY DUE TO EXCESSIVE POLYETHYLENE LINER WEAR. IMPLANTED DEPUY PRODUCTS: AML CUP, POLYETHYLENE LINER, FEMORAL HEAD, AND AML FEMORAL STEM. THIS COMPLAINT CAPTURES THE 6 PATIENTS WITH DEPUY COMPONENTS THAT WERE REVISED DUE TO EXCESSIVE POLYETHYLENE WEAR LABELED CASE 1 THROUGH CASE 6 LINKED TO (B)(4). (B)(6) Y/O FEMALE IMPLANTED WITH 48-MM AML CUP, 32-MM HEAD, 10 +5 AML STEM, AND POLYETHYLENE LINER. CUP AND LINER REVISED 8 YEARS POST-OP DUE TO PROGRESSIVE PAIN SECONDARY TO CUP LOOSENING AND EXCESSIVE POLYETHYLENE LINER WEAR. THERE WAS AN INTRAOPERATIVE ACETABULAR FRACTURE THAT OCCURRED DURING REMOVAL OF THE AML CUP. THERE WERE NO REPORTED PRODUCT PROBLEMS WITH THE STEM OR HEAD. TREATMENT OF THE INTEROPERATIVE FRACTURE WAS NOT PROVIDED BY THE AUTHORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1251441 UNKNOWN HIP ACETABULAR LINERS HIP ACETABULAR LINERS KWZ DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention