BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM MARATHON LINER M 28 10DEG

    MDR report key: 12137973 · Received July 8, 2021

    Report

    Report Number
    1818910-2021-14724
    Event Type
    Injury
    Date Received
    July 8, 2021
    Date of Event
    June 19, 2021
    Report Date
    June 19, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295015840
    PMA / PMN Number
    K924492
    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. EXAMINATION OF THE SINGULAR PROVIDED X-RAY IMAGE DOES NOT DEPICT A DISLOCATION EVENT. THE FEMORAL HEAD IS WELL CENTERED WITHIN THE CUP/LINER CONSTRUCT. NOTHING INDICATIVE OF A PRODUCT PROBLEM IS IDENTIFIED. 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. DEVICE HISTORY LOT THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MATERIAL, MANUFACTURING, INSPECTION OR STERILE PROCESSING THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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 THIS PATIENT HAD HER HIP REPLACED 20+ YEARS AGO, THE SURGEON AND HOSPITAL WHERE THE ORIGINAL PRIMARY HIP TOOK PLACE IS UNKNOWN. DR. (B)(6) REVISED THIS PATIENT'S HIP ON (B)(6) 2021 FOR A WORN OUT ACETABULAR LINER. THE PATIENT DID FINE UNTIL RECENTLY ACCORDING TO DR. (B)(6) BUT HAS DISLOCATED SEVERAL TIMES AFTER BENDING INTO A POSITION TRYING TO CATCH AN ITEM FALLING. WHAT THE ITEM AND POSITION ARE UNKNOWN. THE SURGEON REVISED THE HIP AND EXPLANTED THE LINER AND REPLACED IT WITH A CONSTRAINED LINER AND THE SUPERCUP WAS LEFT IN VITRO. THE STEM AND HIP BALL ARE NOT A DEPUY PRODUCT. THIS IS ALL OF THE INFORMATION AVAILABLE TO ME AT THIS TIME. DOI: (B)(6) , 2021 DOR: (B)(6) 2021 AFFECTED SIDE: RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030427 SROM MARATHON LINER M 28 10DEG S-ROM HIP SYSTEM : HIP POLY ACETABULAR LINERS LPH DEPUY ORTHOPAEDICS INC US 1220-70-128 8540210 10603295015840

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention COMPETITOR HIP BALL/HEAD| COMPETITOR STEM| SROM MARATHON LINER M 28 10DEG| SUPERCUP| COMPETITOR HIP BALL/HEAD| COMPETITOR STEM| SROM MARATHON LINER M 28 10DEG| SUPERCUP