BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP FEMORAL STEM CHARNLEY

    MDR report key: 12355466 · Received August 23, 2021

    Report

    Report Number
    1818910-2021-18387
    Event Type
    Injury
    Date Received
    August 23, 2021
    Date of Event
    January 1, 2021
    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
    UK
    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: A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT NUMBER WAS NOT PROVIDED.

    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

    ARTICLE ENTITLED ¿TOTAL HIP ARTHROPLASTY USING THE WROBLEWSKI GOLF BALL CUP INSERTED THROUGH THE POSTERIOR APPROACH¿ WRITTEN P. PORTER AND M. H. STONE PUBLISHED BY JOURNAL OF BONE AND JOINT SURGERY ON OCTOBER 1, 2003 WAS REVIEWED. THE ARTICLES PURPOSE WAS TO ASCERTAIN IF THE PERCEIVED MECHANICAL ADVANTAGES OF THE WROBLEWSKI GOLF BALL CUP WERE MANIFEST IN CLINICAL PRACTICE. DECEMBER 2000 TO APRIL 2001: 79 THRS WERE RANDOMLY ALLOCATED TO ONE OF THREE CEMENTED ALL-POLYETHYLENE CUP. 35 PATIENTS HAD THE WROBLEWSKI GOLF BALL CUP, 22 PATIENTS HAD THE OGEE LPW CUP, 22 PATIENTS HAD THE WROBLEWSKI ANGLE BORE CUP, CEMENT MFG WAS UNKNOWN FOR ALL THE CUPS. ALL PATIENTS HAD A CHARNLEY ROUNDBACK FEMORAL STEM (MONOBLOCK.) ALL CUPS WERE INSERTED USING THE CHARNLEY CUP HOLDER AT AN INCLINATION OF 45 DEGREES. AND 30 DEGREE ANTEVERSION USING THE CHARNLEY INTRODUCER AND A 30 DEGREE SET SQUARE. ADVERSE EVENTS INVOLVING DEPUY SYNTHES PRODUCTS: NO DISLOCATIONS IN THE OGEE LPW CUP OR WROBLEWSKI ANGLE BORE CUP. 7 PATIENTS EXPERIENCED DISLOCATIONS ALL HAVING THE WROBLEWSKI GOLF BALL CUP. 3 WERE TREATED WITH BEDREST, 2 WITH A HIP BRACE FOR 6 WEEKS, AND 2 UNDERWENT A REVISION TO AN OGEE LPW CUP. NO FURTHER ISSUES AFTER THE REVISION SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253530 UNK HIP FEMORAL STEM CHARNLEY FEMORAL STEM LPH DEPUY INTERNATIONAL LTD - 8010379

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention