BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP ACETABULAR CUP OGEE

    MDR report key: 12350654 · Received August 20, 2021

    Report

    Report Number
    1818910-2021-18311
    Event Type
    Injury
    Date Received
    August 20, 2021
    Date of Event
    January 1, 2003
    Report Date
    August 6, 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. VISUAL EXAMINATION OF THE PROVIDED IMAGES CONFIRMED THE REPORTED EVENT. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT NUMBER WAS NOT PROVIDED. 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 ENTRAPMENT OF A TORN FLANGE OF A CHARNLEY OGEE CUP WRITTEN BY S.G. HAIDAR AND R.J. DINLEY PUBLISHED BY HIP INTERNATIONAL IN 2003 WAS REVIEWED. THE ARTICLES PURPOSE WAS TO DESCRIBE A CASE REPORT DESCRIBING ENTRAPMENT OF THE TORN POSTERIOR FLANGE OF A CHARNLEY OGEE CUP. (B)(6)-YEAR-OLD MAN UNDERWENT A LHA ON 12/9/1995 FOR OSTEOARTHRITIS. A LPW CHARNLEY OGEE CUP WAS PLACED (UNKNOWN CEMENT AND STEM/FEMORAL HEAD). THE PATIENT PRESENTED 34 DAYS LATER WITH A DISLOCATION. REDUCTION WAS CARRIED OUT BY CLOSED REDUCTION. IT WAS NOTED TO BE VERY DIFFICULT, BUT WAS STABLE AFTERWARDS. 35 DAYS LATER THE PATIENT PRESENTED WITH A SECOND DISLOCATION. CLOSED REDUCTION AGAIN WAS VERY DIFFICULT. 45 DAYS LATER, THE PATIENT PRESENTED WITH A THIRD DISLOCATION. THE HIP WAS VERY UNSTABLE ESPECIALLY IN ADDUCTION AND EXTENSION. RADIOGRAPH SHOWED THE FEMORAL HEAD WAS NOT CONCENTRICALLY REDUCE IN THE ACETABULAR CUP. THE HIP WAS EXPLORED, AND THE POSTERIOR HALF OF THE OGEE CUP FLANGE WAS FOUND TO BE TORN OFF IN A BUCKET HANDLE SHAPE. IT WAS TRAPPED ANTERIOR TO THE FEMORAL HEAD, PREVENTING REDUCTION AND CAUSING INSTABILITY. THE TORN FLANGE WAS FREED AND REMOVED. A WEDGE WAS INSERTED TO HELP WITH INSTABILITY AND AVOID DISLOCATIONS. ADVERSE EVENTS INVOLVING DEPUY SYNTHES PRODUCTS: DISLOCATION X3, TORN FLANGE OF THE OGEE CUP, INSTABILTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243795 UNK HIP ACETABULAR CUP OGEE POLY ACETABULAR CUP LPH DEPUY INTERNATIONAL LTD - 8010379

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention