BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SROM OSZ DIST/PRX TRL 13/20

    MDR report key: 12107738 · Received July 2, 2021

    Report

    Report Number
    1818910-2021-14231
    Event Type
    Malfunction
    Date Received
    July 2, 2021
    Date of Event
    June 16, 2021
    Report Date
    June 16, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LXH
    UDI-DI
    10603295146186
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # : (B)(4). INVESTIGATION SUMMARY : THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. 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 REVIEW : THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE S-ROM OVERSIZED STEM TRIAL THREADS WERE DAMAGED AND THE TRIAL NECK WOULD NOT TIGHTEN. THREADS WERE STRIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004924 SROM OSZ DIST/PRX TRL 13/20 INSTRUMENT HIP STEM TRIAL LXH DEPUY ORTHOPAEDICS INC US 2576-13-020 MT0709 10603295146186

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR