BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 9397524 · Received December 2, 2019

    Report

    Report Number
    1818910-2019-118296
    Event Type
    Injury
    Date Received
    December 2, 2019
    Date of Event
    October 24, 2002
    Report Date
    November 6, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE(S) 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. CORRECTIVE ACTION WAS NOT INDICATED. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    "LITERATURE ARTICLE ENTITLED, ¿PRIMARY TOTAL HIP ARTHROPLASTY WITH A BURCH-SCHNEIDER ANTIPROTRUSION CAGE AND AUTOLOGOUS BONE GRAFTING FOR ACETABULAR FRACTURES IN ELDERLY PATIENTS¿ BY JAN TIDERMARK, ET AL, PUBLISHED BY JOURNAL OF ORTHOPAEDIC TRAUMA (2003), VOL. 17, NO. 3, PP. 193-197, WAS REVIEWED. THE PURPOSE OF THIS ARTICLE WAS TO INVESTIGATE THE CLINICAL AND FUNCTIONAL OUTCOME IN AN ELDERLY POPULATION WITH ACETABULAR FRACTURES AFTER LOW ENERGY TRAUMA TREATED ACUTELY WITH A TOTAL HIP ARTHROPLASTY SUPPORTED BY A COMPETITOR REINFORCEMENT RING (ANTIPROTRUSION CAGE AND ASSOCIATED COMPETITOR SCREWS) AND AUTOLOGOUS BONE GRAFTING OF THE ACETABULUM. THIS STUDY IS BASED ON A RETROSPECTIVE REVIEW OF 14 CONSECUTIVE PATIENTS WITH ACETABULAR FRACTURES TREATED ACUTELY WITH A THA BETWEEN 1993 AND 1999. THE PATIENTS INCLUDED WERE ELDERLY (>55 YEARS) WITH CLINICALLY ESTABLISHED OSTEOPOROSIS AND AN ACUTE DISPLACED ACETABULAR FRACTURE (FRACTURE DISPLACEMENT >1 CM IN THE WEIGHTBEARING PART OF THE JOINT AND/OR PROTRUSION >1 CM) AFTER A LOW-ENERGY TRAUMA. THE ACETABULUM IN EACH PATIENT WAS RECONSTRUCTED WITH A COMPETITOR REINFORCEMENT RING SECURED WITH COMPETITOR SCREWS AND COMPETITOR ALLOGRAFT MATERIAL AND A CHARNLEY POLYETHYLENE CUP WAS CEMENTED WITH COMPETITOR CEMENT. THE FEMORAL COMPONENTS WERE CHARNLEY. THE STEMS WERE CEMENTED WITH COMPETITOR CEMENT. THE AUTHORS PROVIDE DETAILED PATIENT OUTCOMES ON TABLE 1 ON PAGE 194. PATIENT 2, 4, 8, 9, AND 10 HAD NO COMPLICATIONS OR REVISIONS AND WILL NOT BE INCLUDED IN THIS COMPLAINT. THIS COMPLAINT CAPTURES 5 PATIENTS LABELED CASE 1, CASE 2, CASE 3, CASE 4, AND CASE 5 IN THE ATTACHED GUIDANCE DOCUMENT. THIS PARENT (B)(4) CAPTURES ONE DEEP VEIN THROMBOSIS IDENTIFIED BY THE AUTHORS BUT NOT ASSOCIATED WITH A SPECIFIC PATIENT. TREATMENT FOR THE DEEP VEIN THROMBOSIS WAS NOT PROVIDED BY THE AUTHORS." (B)(6) YO MALE IMPLANTED WITH A CHARNLEY POLYETHYLENE CUP, FEMORAL HEAD, AND CHARNLEY STEM. THE CUP AND STEM WERE CEMENTED WITH COMPETITOR CEMENT. THE CUP WAS CEMENTED INTO A COMPETITOR ACETABULAR REINFORCEMENT CAGE SECURED WITH COMPETITOR SCREWS. THE PATIENT HAD ONE DISLOCATION AT 2 MONTHS AND A SECOND DISLOCATION AT 12 MONTHS. BOTH WERE TREATED WITH CLOSED REDUCTION UNDER GENERAL ANESTHESIA. THERE WERE NO FURTHER DISLOCATIONS. THE AUTHORS NOTE THAT DISLOCATIONS MAY BE ATTRIBUTED TO THE PATIENT'S POSTOPERATIVELY RECOGNIZED ALCOHOL ABUSE. THERE WERE NO REVISIONS PERFORMED TO TREAT THE DISLOCATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193360 UNKNOWN HIP FEMORAL HEAD HIP FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention