BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR CUP

    MDR report key: 7832204 · Received August 30, 2018

    Report

    Report Number
    1818910-2018-68103
    Event Type
    Injury
    Date Received
    August 30, 2018
    Date of Event
    August 4, 2018
    Report Date
    August 4, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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: PINN MAR +4 10D 28IDX46OD; DELTA CER HEAD 12/14 28MM +1.5; UNKNOWN HIP FEMORAL STEM; UNKNOWN HIP ACETABULAR CUP.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: THE ACETABULAR CUP ASSOCIATED WITH THIS REPORT WAS NOT RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. 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 WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE PATIENT HAD PTQ 4 YEARS AGO AND HER INSERT WAS DISPLACED FROM THE ACETABULUM. I FORWARD PHOTOS OF THE PRIMARY EXAMINATION, THE CASE OF THE EVOLUTION OF THE CASE AND ALSO THE BOX WITH THE IMPLANTS FOR ANALYSIS. THE PATIENT DID NOT NEED TO BE HOSPITALIZED FOR THIS REASON, NOR DID SHE HAVE ANY COMPLICATIONS DURING THE SURGERY. PRODUCT INFORMATION: REF. 1219-28-146, LOT 132163 - ACETABULAR LINER 28MM; REF. 1365-28-310, LOT 3512554 - CERAMIC FEMORAL HEAD 28 MM 12/14. THE REVIEW WAS PERFORMED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676357 UNKNOWN HIP ACETABULAR CUP HIP ACETABULAR CUP KWA DEPUY ORTHOPAEDICS, INC. 1818910

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention