BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR POLY/METAL HEMI

    MDR report key: 8522380 · Received April 17, 2019

    Report

    Report Number
    1818910-2019-90872
    Event Type
    Injury
    Date Received
    April 17, 2019
    Report Date
    March 25, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LITERATURE ARTICLE REVIEW. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PMA/510K: THIS REPORT IS FOR AN UNKNOWN DEVICE/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    A LITERATURE ARTICLE WAS RECEIVED ENTITLED: "IS BIPOLAR HEMIARTHROPLASTY A RELIABLE OPTION FOR FICAT STAGE III OSTEONECROSIS OF THE FEMORAL HEAD? 15- TO 24-YEAR FOLLOW-UP STUDY", BY KYU-TAE HWANG, ET. AL, PUBLISHED IN ARCH ORTHOP TRAUMA SURG (2012) 132:1789¿1796. THE STUDY SOUGHT TO DETERMINE RELIABILITY OF BIPOLAR HEMIARTHROPLASTY AS A TREATMENT FOR OSTEONECROSIS OF THE FEMORAL HEAD. THE DEPUY SELF-CENTERING BIPOLAR DEVICE WAS USED ON ALL 55 HIPS, PAIRED WITH EITHER A DEPUY TRILOCK FEMORAL STEM (32 HIPS) OR A DEPUY GEMINI FEMORAL STEM (23 HIPS), AND AN APPROPRIATE DEPUY METAL FEMORAL HEAD, FOR A METAL ON POLYETHYLENE BEARING IN ALL HIPS. TEN HIPS WERE REVISED OVER THE LENGTH OF THE STUDY: TWO HIPS WERE REVISED FOR GROIN PAIN, ASSOCIATED WITH LOSS OF ACETABULAR CARTILAGE AND OSTEOLYSIS, AND THE OTHER EIGHT WERE REVISED TO ADDRESS GROIN PAIN WITH SUPEROMEDIAL MIGRATION OF THE CUP WITH ACETABULAR PROTRUSION (EROSION) AND OSTEOLYSIS. THERE WERE NO REPORTS OF DISLOCATION, STEM LOOSENING, OR INFECTION. THE AUTHORS DID NOT PROVIDE ANY CASE/PATIENT SPECIFIC ACCOUNTS, NOR ANY SPECIFIC PRODUCT OR LOT CODE INFORMATION FOR ANY OF THE IMPLANTED PRODUCTS. THIS REPORT ADDRESSES TEN INSTANCES INVOLVING THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316314 UNKNOWN HIP ACETABULAR POLY/METAL HEMI HIP ACETABULAR POLY/METAL HEMI KWA DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention