BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP FEMORAL STEM CHARNLEY

    MDR report key: 12355453 · Received August 23, 2021

    Report

    Report Number
    1818910-2021-18429
    Event Type
    Injury
    Date Received
    August 23, 2021
    Date of Event
    January 25, 2011
    Report Date
    August 5, 2021
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (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. 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

    ARTICLE ENTITLED ¿WEAR AND MIGRATION OF HIGHLY CROSS-LINKED AND CONVENTIONAL CEMENTED POLYETHYLENE CUPS WITH COBALT CHROME OR OXINIUM FEMORAL HEADS: A RANDOMIZED RADIOSTEREOMETRIC STUDY OF 150 PATIENTS" WRITTEN BY THOMAS KADAR, GEIR HALLAN, ARILD AAMODT, KARI INDREKVAM, MONA BADAWY, ARNE SKREDDERSTUEN, LEIF IVAR HAVELIN, TERJE STOKKE, KRISTIN HAUGAN, BIRGITTE ESPEHAUG, OVE FURNES, PUBLISHED BY THE JOURNAL OF ORTHOPAEDIC RESEARCH AUGUST 2011, WAS REVIEWED. THIS RANDOMIZED STUDY WAS PERFORMED TO COMPARE WEAR AND MIGRATION OF FIVE DIFFERENT CEMENTED TOTAL HIP JOINT ARTICULATIONS IN 150 PATIENTS. THE PATIENTS RECEIVED EITHER A CHARNLEY FEMORAL STEM WITH A 22.2 MM HEAD OR A SPECTRON EF FEMORAL STEM WITH A 28 MM HEAD. THE CHARNLEY ARTICULATED WITH A G-STERILIZED CHARNLEY OGEE ACETABULAR CUP. THE SPECTRON EF WAS USED WITH EITHER ETO STERILIZED NON-CROSS-LINKED POLYETHYLENE (REFLECTION ALL-POLY) OR HIGHLY CROSS-LINKED (REFLECTION ALL-POLY XLPE) CUPS, COMBINED WITH EITHER COBALT CHROME (COCR) OR OXINIUM FEMORAL HEADS. THE PATIENTS WERE FOLLOWED WITH REPEATED RSA MEASUREMENTS FOR 2 YEARS. AFTER 2 YEARS, THE ETO STERILIZED NON-CROSS-LINKED REFLECTION ALL-POLY CUPS HAD MORE THAN FOUR TIMES HIGHER PROXIMAL PENETRATION THAN ITS HIGHLY CROSS-LINKED COUNTERPART. USE OF OXINIUM FEMORAL HEADS DID NOT AFFECT PENETRATION AT 2 YEARS COMPARED TO HEADS MADE OF COCR. FURTHER FOLLOW-UP IS NEEDED TO EVALUATE THE BENEFITS, IF ANY, OF OXINIUM FEMORAL HEADS IN THE CLINICAL SETTING. THE CHARNLEY OGEE WAS NOT OUTPERFORMED BY THE MORE RECENTLY INTRODUCED IMPLANTS IN OUR STUDY. WE CONCLUDE THAT THIS PROSTHESES STILL REPRESENTS A STANDARD AGAINST WHICH NEW IMPLANTS CAN BE MEASURED. THIS ARTICLE CAPTURES RESULTS FOR BOTH COMPETITOR AND DEPUY PRODUCTS. THE AUTHORS DO NOT SPECIFY THE MANUFACTURER ASSOCIATED WITH THE RESULTS. THE TOTAL NUMBER OF DEPUY PRODUCTS ASSOCIATED WITH THE FOLLOWING ADVERSE EVENTS IS UNKNOWN. WE WILL BE REPORTING AN UNKNOWN CHARNLEY OGEE ACETABULAR CUP AND UNKNOWN CHARNLEY FEMORAL STEM. FINDINGS: 5 INFECTIONS, 5 DISLOCATION, GENERAL FINDINGS OF MIGRATION AND DEBRIS WEAR, OSTEOLYSIS. DEPUY PRODUCTS: CHARNLEY OGEE ACETABULAR CUP, CHARNLEY FEMORAL STEMJ, COMPETITOR CEMENT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253398 UNK HIP FEMORAL STEM CHARNLEY FEMORAL STEM LPH DEPUY INTERNATIONAL LTD - 8010379

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention