BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 9141651 · Received October 1, 2019

    Report

    Report Number
    1818910-2019-107082
    Event Type
    Injury
    Date Received
    October 1, 2019
    Date of Event
    December 27, 2007
    Report Date
    September 13, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. (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

    LITERATURE ARTICLE ENTITLED, ¿IMPACTION GRAFTING OF THE ACETABULUM WITH CERAMIC BONE GRAFT SUBSTITUTE¿ BY MICHAEL R WHITEHOUSE, ET AL, PUBLISHED BY ACTA ORTHOPAEDICA (2013), VOL. 84, NO. 4, PP. 371-376, WAS REVIEWED FOR MDR REPORTABILITY. THIS ARTICLE REVIEWS THE EFFICACY OF ALLOGRAFT IMPACTION GRAFTING OF THE ACETABULUM. THE AUTHORS CONDUCTED A RETROSPECTIVE REVIEW OF A COHORT OF 43 CONSECUTIVE PATIENTS UNDERGOING IMPACTION GRAFTING OF CONTAINED ACETABULAR DEFECTS. 43 PATIENTS (26 FEMALE) UNDERWENT REVISION HIP ARTHROPLASTY WITH GRAFTING OF BONE SUBSTITUTE ALONE BETWEEN JULY 2004 AND OCTOBER 2010. ALL PATIENTS RECEIVED UNCEMENTED ACETABULAR COMPONENTS FROM A VARIETY OF MANUFACTURERS. THE IMPLANTED DEPUY ACETABULAR COMPONENTS WERE 28 PINNACLE AND 4 DURALOC, WITH AND WITHOUT SCREWS. 15 CEMENTED FEMORAL DEPUY C-STEM AMTS AND 10 DEPUY UNCEMENTED FEMORAL STEMS (9 KAR AND 1 S-ROM) WERE USED. MOM, MOP, AND COC ARTICULATIONS WERE USED. MEDIAN AGE AT SURGERY WAS 73. FOR PATIENTS WHO REMAINED ALIVE AT FINAL FOLLOW-UP, THE MEAN TIME WAS 51 MONTHS. WHEN PATIENTS WHO HAD DIED WERE INCLUDED, THE MEAN FOLLOW-UP UNTIL FINAL FOLLOW-UP OR DEATH WAS 49 MONTHS. THE DEATHS WERE NOT ATTRIBUTED TO THE IMPLANTED PROSTHESES. OF THE 38 PATIENTS WHO REMAINED ALIVE AT FINAL FOLLOW-UP, 36 OF THEM RETURNED COMPLETED QUESTIONNAIRES. RADIOGRAPHIC FOLLOW-UP WAS AVAILABLE IN 37 CASES. 1 CASE HAD MIGRATED AND WAS CONSIDERED A RADIOGRAPHIC FAILURE, BUT THE PATIENT WAS NOT FIT TO UNDERGO FURTHER REVISION SURGERY. NO OSTEOLYSIS OR ACCELERATED POLYETHYLENE WEAR WAS OBSERVED. BROOKER GRADE 0 WAS RECORDED IN 21 CASES, GRADE 1 IN 12 CASES, GRADE 2 IN 2 CASES, AND GRADE 3 IN 2 CASES. IN 4 CASES, THE BROOKER GRADE WAS WORSE THAN PREOPERATIVELY AND IN 2 CASES THE GRADE HAD DECREASED. GRAFT WAS VISIBLE IN THE SOFT TISSUES IN 2 CASES: 1 WAS BROOKER GRADE 0 AND 1 WAS GRADE 1 AND HAD BEEN PREOPERATIVELY. OF THE 37 CASES WITH RADIOGRAPHIC FOLLOW-UP, NO RADIOLUCENCY WAS OBSERVED IN 17 CASES. 1 OF THE 2 CASES WITH RADIOLUCENCY IN ALL 3 ZONES WAS THE RADIOGRAPHIC FAILURE ALREADY DESCRIBED; THE OTHER CASE HAD AN OHS OF 29. 1 ACETABULAR COMPONENT WAS REVISED FOR INFECTION 16 MONTHS AFTER THE INDEX THA. 1 PATIENT REQUIRED REVISION OF THE FEMORAL STEM ONLY FOR ASEPTIC LOOSENING (5.5 YEARS). 6 PATIENTS REQUIRED UNSPECIFIED REOPERATIONS THAT DID NOT INVOLVE REVISION OF THE IMPLANTED PRODUCTS. 2 RADICAL DEBRIDEMENT PROCEDURES WERE PERFORMED FOR INFECTION (AT 1 WEEK AND 3 WEEKS), 2 FEMURS REQUIRED SUPPLEMENTARY STRUT GRAFTING OF THE FEMUR (AT 2 WEEKS AND 5.5 YEARS), 1 PATIENT REQUIRED CLOSED REDUCTION FOR DISLOCATION FOLLOWING A FALL (AT 1 WEEK), AND 1 PATIENT UNDERWENT AN EXAMINATION UNDER ANESTHETIC TO ASSESS SUBLUXATION (AT 1.5 YEARS); THE HIP WAS FOUND TO BE STABLE. THE AUTHORS DO NOT SPECIFY WHICH ADVERSE EVENT APPLIES TO WHICH MANUFACTURER OR COMPONENT NOR DO THEY IDENTIFY THE TYPES OF ARTICULATING SURFACES INVOLVED IN EACH EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934600 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM JDI DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention