BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 12850118 · Received November 21, 2021

    Report

    Report Number
    1818910-2021-25828
    Event Type
    Injury
    Date Received
    November 21, 2021
    Date of Event
    November 4, 2021
    Report Date
    November 4, 2021
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. HOWEVER A PHOTOGRAPH WAS PROVIDED. UPON VISUAL INSPECTION OF THE PHOTOGRAPH, NO EVIDENCE OF IMPLANT FRACTURE, DISASSOCIATION, OR ANYTHING INDICATIVE OF A DEVICE NONCONFORMANCE WAS FOUND. THE DEVICE WAS SHOWED WITH BLOOD RESIDUES. 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. DEVICE HISTORY LOT: PREVIOUS INVESTIGATIONS THAT HAVE INCLUDED MANUFACTURING RECORD EVALUATIONS (MRE) SINCE THE ASR PLATFORM WAS LAUNCHED HAVE SHOWN NO INDICATION OF DEVIATIONS OR ANOMALIES WITH REGARD TO MATERIAL, MANUFACTURING OR INSPECTION.

    Additional Manufacturer Narrative · 0

    (B)(4). 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 · 0

    IT WAS REPORTED THAT PATIENT PRESENTED TO VCU FROM MWH TRANSFER. SURGEON SEEN PATIENT BLOOD WORK SHOWED HIGH ION LEVELS. SURGEON WANTED TO REVISE IT FROM METAL ON METAL. NO FURTHER INFORMATION AVAILABLE. UNKNOWN ION LEVEL, HAVE TO INVITE WITH HOSPITAL. SLEEVE IS NOT ABLE TO BE SEEN FOR INFO. IN DER, ACETABULAR CUP WAS LOOSE IN NON CEMENTED INTERFACE. DOI: EARLY 2000, DOR: (B)(6) 2021, LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1747647 ASR UNI FEMORAL IMPL SIZE 45 ASR HIP SYSTEM : HIP METAL FEMORAL HEADS KWA DEPUY INTERNATIONAL LTD - 8010379 2546381

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention ASR ACETABULAR CUPS 50.| ASR UNI FEMORAL IMPL SIZE 45.| UNK HIP FEMORAL SLEEVE ASR.| UNKNOWN HIP FEMORAL STEM.