BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 12091884 · Received June 30, 2021

    Report

    Report Number
    1818910-2021-13922
    Event Type
    Injury
    Date Received
    June 30, 2021
    Report Date
    June 8, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT NUMBER WAS NOT PROVIDED. BASED ON PREVIOUS INVESTIGATIONS, THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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. DEVICE HISTORY LOT : 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). WHERE THE LOT CODE WAS PROVIDED, 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 IN 1993 THE PRIMARY SURGERY WAS PERFORMED WITH THE CUP. AFTER THE SURGERY, ON UNKNOWN DATE, AML-A CUP REPLACEMENT SURGERY WAS PERFORMED. THE PLACE WHERE THE CUP WAS PLACED WAS BAD, AND THE PLACE WHERE THE LOAD WAS PLACED WAS DEVIATED FROM THE CENTER. HEAD, LINER, 6 SCREWS, AND CUP WERE REMOVED. IBG WAS PERFORMED ON OSTEOLYSIS BY OSTEOLYSIS AND FIXED WITH KT PLATE AND CEMENT CUP. ONE SCREW WAS BROKEN, BUT THE SURGEON DECIDED TO LEAVE IT AS IS. SINCE THE STEM DID NOT LOOSEN, THE SURGERY WAS COMPLETED WITHOUT REMOVING IT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991818 UNKNOWN HIP FEMORAL HEAD HIP FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention AML-A CUP| UNK HIP BONE SCREW| UNK HIP BONE SCREW| UNK HIP BONE SCREW| UNK HIP BONE SCREW| UNK HIP BONE SCREW| UNK HIP BONE SCREW| UNKNOWN HIP ACETABULAR LINERS| UNKNOWN HIP FEMORAL HEAD| UNKNOWN HIP FEMORAL STEM| AML-A CUP| UNK HIP BONE SCREW| UNK HIP BONE SCREW| UNK HIP BONE SCREW| UNK HIP BONE SCREW| UNK HIP BONE SCREW| UNK HIP BONE SCREW| UNKNOWN HIP ACETABULAR LINERS| UNKNOWN HIP FEMORAL HEAD| UNKNOWN HIP FEMORAL STEM