BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 15065237 · Received July 20, 2022

    Report

    Report Number
    1818910-2022-13506
    Event Type
    Injury
    Date Received
    July 20, 2022
    Date of Event
    January 1, 2022
    Report Date
    July 20, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED. DEVICE HISTORY LOT : A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. LITERATURE CITATION: KIM YH, PARK JW, JANG YS, KIM EJ. LONG-TERM (UP TO 38 YEARS) FAILURE MODES OF TOTAL HIP ARTHROPLASTY IN ADULT PATIENTS WHO HAD CHILDHOOD INFECTION OF HIP. J ARTHROPLASTY. 2022 MAR 24:S0883-5403(22)00348-5. DOI: 10.1016/J.ARTH.2022.03.064. EPUB AHEAD OF PRINT. PMID: 35341924. OBJECTIVE/METHODS/STUDY DATA: AUTHORS REVIEWED THE RESULTS OF 142 PATIENTS (145 HIPS) (MEAN AGE 41.9 YEARS). THE AGE OF THE PATIENTS AT THE TIME THAT THE INFECTION WAS CONTRACTED WAS AN AVERAGE OF 7.1 YEARS (RANGE 1-11). THE AVERAGE INTERVAL BETWEEN ACTIVE INFECTION AND THA WAS 34.5 YEARS. ALL BUT 2 HIPS (1 PATIENT) HAD A QUIESCENT PERIOD OF INFECTION OF MORE THAN 10 YEARS. THE AVERAGE DURATION OF FOLLOW-UP AFTER THA WAS 31.5 YEARS (RANGE 25-38). IT IS NOTED THAT DURING FOLLOW UP 3 PATIENTS HAD DIED BUT THERE IS NO INDICATION AS TO CAUSE, AND THE ARTICLE DOES NOT REPORT THAT THESE DEATHS ARE RELATED TO THE MEDICAL DEVICES. CEMENT MANUFACTURER IS NOT IDENTIFIED IN THE ARTICLE. THE FOLLOWING IS THE LIST OF NOTED DEPUY DEVICES NOTED IN THE DATA SET OF THE STUDY AS REPORTED BY THE ARTICLE: CEMENTED FEMORAL PROSTHESIS: QTY 11 ELITE CDH, QTY 20 ELITE - THESE WERE UTILIZED WITH DURLAOC 1200 SERIES CEMENTLESS CUPS UNCEMENTED POROUS COATED PROSTHESIS: QTY 15 AML & QTY 12 BATAM - THESE WERE UTILIZED WITH CEMENTLESS AML TYPE ACETABULAR CUPS; QTY 48 PROFILE & QTY 26 IPS - THESE WERE UTILIZED WITH DURALOC 12000 SERIES CEMENTLESS ACETABULAR CUPS THE FOLLOWING IS THE LIST OF NOTED NON-DEPUY DEVICES NOTED IN THE DATA SET OF THE STUDY AS REPORTED BY THE ARTICLE: CEMENT FEMORAL PROSTHESIS: QTY 8 MULLER CONGENITAL DYPLASTIC (THACKARY) UTILIZED WITH ALL POLY ACETABULAR CUPS UNCEMENTED POROUS COATED PROSTHESIS: QTY 21 PCA (HOWMEDICA) UTILIZED WITH CEMENTLESS PCA ACETABULAR CUPS FIGURE 1 DEPICTS A 47 YEARS OLD WOMAN WITH IMPLANTED MEDICAL DEVICES BUT DOES NOT IDENTIFY THE MANUFACTURER OF THE IMPLANTS. CAPTION NOTES NO ADVERSE EVENTS AND STATES "COMPONENTS ARE WELL FIXED IN A SATISFACTORY POSITION." FIGURE 2 DEPICTS A 21 YEARS OLD WOMAN WITH IMPLANTED MEDICAL DEVICES BUT DOES NOT IDENTIFY THE MANUFACTURER OF THE IMPLANTS. CAPTION NOTES NO ADVERSE EVENTS AND STATES "COMPONENTS ARE WELL FIXED IN A SATISFACTORY POSITION." THE ARTICLE DOES NOT IDENTIFY THE MANUFACTURER'S DEVICES ASSOCIATED WITH THE ADVERSE EVENT; HOWEVER, THE PROVIDED NUMBERS INDICATE THAT AT LEAST ONE OF THE DEPUY PRODUCTS WOULD HAVE BEEN REVISED. THEREFORE, THIS COMPLAINT CAPTURES THE QUANTITIES OF ADVERSE EVENTS THAT REASONABLY CAN BE CONCLUDED TO INCLUDE A DEPUY PRODUCT UNTIL FURTHER INFORMATION CAN BE PROVIDED FROM AUTHOR(S). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS (DEVICE MANUFACTURER IS NOT IDENTIFIED): TOTAL QTY 78 ISOLATED CUP REVISIONS WITH 63 REMOVED BECAUSE OF EXTENSIVE PERIPROSTHETIC OSTEOLYSIS , 10 BECAUSE OF ASEPTIC LOOSENING AND OSTEOLYSIS, AND 5 BECAUSE OF RECURRENT DISLOCATION - REASONABLE TO CONCLUDE AT LEAST 49 CUPS REVISED WOULD BE A DEPUY PRODUCT. FURTHER INFORMATION IS REQUIRED TO CLARIFY IF DEPUY PRODUCTS ARE INVOLVED IN THE DISLOCATION. TOTAL QTY 30 FEMORAL COMPONENTS WERE REVISED DUE TO ASEPTIC LOOSENING AND/OR OSTEOLYSIS (3 CEMENTLESS STEMS AND 27 CEMENTED STEMS) - REASONABLE TO CONCLUDE AT LEAST 19 CEMENTED STEMS WOULD BE DEPUY PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400388 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention