BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*SLEEVE PRX ZTT, 16B-LRG

    MDR report key: 11771338 · Received May 4, 2021

    Report

    Report Number
    1818910-2021-09503
    Event Type
    Injury
    Date Received
    May 4, 2021
    Date of Event
    April 19, 2021
    Report Date
    April 19, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295170624
    PMA / PMN Number
    P070026
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS 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. DEVICE HISTORY LOT : A DEVICE HISTORY RECORD (MRE) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    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 DR PERFORMED THE PATIENTS INITIAL SURGERY ON (B)(6) 2009. PATIENT WAS COMPLAINING OF SOME THIGH PAINS. WHEN LOOKING AT THE X-RAY, DR K NOTICED THAT STEM APPEARED TO HAVE SHIFTED INTO VARUS. HE DECIDED THIS COULD BE THE CAUSE FOR HER DISCOMFORT AND FELT SHE WOULD BENEFIT FROM A REMOVAL OF THE SROM STEM. THE FEMORAL HEAD AND STEM WERE REMOVED AS WELL AS THE ACETABULAR LINER. HE IMPLANTED A COMPETITOR STEM WITH THEIR 32MM HEAD. A NEW LINER WAS IMPLANTED FOR THE PINNACLE CUP AND A TRIAL REDUCTION WAS PERFORMED. HIP WAS FOUND TO BE STABLE AND THE CLOSING PROCESS BEGAN. DOI: (B)(6) 2009; DOR: (B)(6) 2021; RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669252 S-ROM*SLEEVE PRX ZTT, 16B-LRG S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE LPH DEPUY ORTHOPAEDICS INC US 52-1465 10603295170624

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention ALTRX +4 10D 32IDX48OD| DELTA CER HEAD 11/13 32MM +3| SROM*STM ST,30+4L NK,16X11X150