BEUDAMED
    FDA Adverse Event Injury Summary report: N

    P.F.C.* 28MM HEAD +10MM

    MDR report key: 7757548 · Received August 7, 2018

    Report

    Report Number
    1818910-2018-65928
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    July 11, 2018
    Report Date
    July 11, 2018
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    KWY
    UDI-DI
    10603295207603
    PMA / PMN Number
    K893872
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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. CONCOMITANT MEDICAL PRODUCTS: PFC CE STM SZ 1.5/10/12 TAPER 852752, LOT: 1933199.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REVISIONS SURGERY WAS PERFORMED ON (B)(6) 2018 (DATE OF THE PRIMARY SURGERY WAS UNKNOWN) BY REPLACING THE STEM, THE HEAD, AND THE CUP DUE TO FREQUENT DISLOCATION. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599157 P.F.C.* 28MM HEAD +10MM PFC FEMORAL HEADS (10/12) : HIP METAL FEMORAL HEADS KWY DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN 10603295207603

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention