BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 9347491 · Received November 20, 2019

    Report

    Report Number
    1818910-2019-116783
    Event Type
    Injury
    Date Received
    November 20, 2019
    Date of Event
    September 27, 2006
    Report Date
    October 30, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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, ¿COMPARISON OF RE-OPERATION RATES FOLLOWING PRIMARY AND SECONDARY HEMIARTHROPLASTY OF THE HIP¿ BY FREDE FRIHAGEN, ET AL, PUBLISHED BY INJURY: INTERNATIONAL JOURNAL OF THE CARE OF THE INJURED (2007), VOL. 38, PP. 815-819, WAS REVIEWED. THE AIM OF THE PRESENT STUDY WAS TO COMPARE THE RATE OF RE-OPERATIONS BECAUSE OF SURGICAL COMPLICATIONS AFTER PRIMARY AND SECONDARY HEMIARTHROPLASTIES AFTER FEMORAL NECK FRACTURES. ALL HEMIARTHROPLASTIES PERFORMED BETWEEN JANUARY 1998 AND MARCH 2002 WERE RESPECTIVELY RECORDED. THERE WERE 282 HIPS OPERATED FOR AN ACUTE FRACTURE OF THE FEMORAL NECK, AND 149 CASES WITH A SECONDARY ARTHROPLASTY AFTER FAILURE OF FIXATION WITH TWO PARALLEL COMPETITOR SLIDING HIP SCREWS. THE FOLLOW-UP DATA WERE EXTRACTED RETROSPECTIVELY FROM THE MEDICAL RECORDS BETWEEN JUNE 2003 AND JUNE 2004, 19¿74 MONTHS AFTER THE HEMIARTHROPLASTY SURGERY. THE AUTHORS DEFINED PRIMARY HRAS AS THOSE USED TO TREAT PREOPERATIVE FEMORAL FRACTURES. PATIENTS TREATED WITH HRAS AFTER FAILURE OF THE COMPETITOR ORIF WERE PLACED IN THE SECONDARY HRA GROUP. DEPUY PRODUCTS USED: HRA IMPLANTS WERE CEMENTED CHARNLEY STEMS PAIRED WITH A HASTINGS BIPOLAR FEMORAL HEAD. THE MANUFACTURER OF THE CEMENT IS UNKNOWN. ORIF DEVICES WERE COMPETITOR PRODUCTS. RESULTS: THERE WERE A TOTAL OF 31 REOPERATIONS OR SURGICAL INTERVENTIONS PERFORMED IN THE STUDY. 9 INFECTIONS TREATED WITH INCISION AND DEBRIDEMENT SURGERY- IMPLANTS RETAINED. 7 INFECTIONS TREATED WITH INCISION AND DEBRIDEMENT WITH EXCHANGE OF THE BIPOLAR HEAD CUP. 6 DISLOCATIONS TREATED WITH CLOSED REDUCTION UNDER ANESTHESIA. 1 DISLOCATION TREATED WITH OPEN REDUCTION, NATURAL ACETABULAR REAMING, AND EXCHANGE OF THE BIPOLAR HEAD CUP TO A LARGER SIZE. 2 PERIPROSTHETIC FRACTURES TREATED WITH ORIF OF COMPETITOR PLATING. THE PATIENTS REPORTED PAIN AND DECREASED RANGE OF MOTION. 2 EXCISION ARTHROPLASTIES AS RE-REVISION FOR INFECTION AND PAIN. 1 SURGICAL REMOVAL OF LEAKED CEMENT FROM SOFT TISSUE. THE MANUFACTURER OF THE CEMENT WAS UNKNOWN. THE LEAKED CEMENT IS NOT ATTRIBUTED TO THE FEMORAL STEM OR HASTINGS BIPOLAR FEMORAL HEAD. 3 POSTOPERATIVE HEMATOMAS TREATED WITH INCISION AND DEBRIDEMENT WITH EXCHANGE OF THE BIPOLAR HEAD. THE AUTHORS NOTE THERE WERE 23 DEATHS WITHIN 30 DAYS OF HRA IMPLANTATION IN PATIENT WITH ¿SIGNIFICANT COMORBIDITIES¿. THE AUTHORS DO NOT ATTRIBUTE THE POSTOPERATIVE DEATHS TO THE SURGICAL PROCEDURE OR THE IMPLANTED DEPUY COMPONENTS. CAPTURED IN THIS COMPLAINT: THE INDEX HRA INCLUDES THE CHARNLEY STEM: NO REPORTED PRODUCT PROBLEM; BIPOLAR HEAD CUP: IMPLANT DISLOCATION: HIP; BIPOLAR HEAD: NO REPORTED PRODUCT PROBLEM. PATIENT HARMS: INFECTION, HEMATOMA, JOINT DISLOCATION, FRACTURE POST-OP, SURGICAL INTERVENTION, PAIN, MEDICAL DEVICE SITE JOINT RANGE OF MOTION DECREASED. RE-REVISION COMPONENTS INCLUDE AN ADDITIONAL CHARNLEY STEM AND HASTINGS BIPOLAR HEADS: NO REPORTED PRODUCT PROBLEM, INFECTION, MEDICAL DEVICE REMOVAL, PAIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143100 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM JDI DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention