BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 9348533 · Received November 20, 2019

    Report

    Report Number
    1818910-2019-115487
    Event Type
    Injury
    Date Received
    November 20, 2019
    Date of Event
    October 25, 2016
    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).

    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. 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 COMPLAINT INFORMATION PROVIDED HAS BEEN REVIEWED FOR COMPLAINT CODING, MEDICAL DEVICE REPORTING, AND OTHER DATA REQUIRED BY THE COMPLAINT SYSTEM. FOLLOW-UP FOR ADDITIONAL EVENT INFORMATION, IF APPLICABLE, WAS CONDUCTED UTILIZING WORK INSTRUCTION (B)(4) APPENDIX A. WITHOUT THE PHYSICAL COMPLAINT SAMPLE(S) ASSOCIATED WITH THIS REPORT, IT WAS NOT POSSIBLE TO DETERMINE IF THE DEVICE(S) FAILED TO MEET SPECIFICATION(S) AT THE TIME IT WAS RELEASED FOR DISTRIBUTION. THE DEVICE(S) ASSOCIATED WITH THIS EVENT WERE USED IN THE TREATMENT OF THE PATIENT AS PRESCRIBED BY THE PRESIDING SURGEON. FROM THE EVENT INFORMATION RECEIVED, IT WAS NOT POSSIBLE TO DETERMINE THE RELATIONSHIP OF THE DEVICE TO THE REPORTED EVENT. NO INFORMATION RECEIVED WITH THIS INDIVIDUAL COMPLAINT INDICATES THAT A BROADER INVESTIGATION OR CORRECTIVE ACTION WAS NECESSARY. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. POST MARKET SURVEILLANCE IS PER (B)(4).

    Description of Event or Problem · 1

    "LITERATURE ARTICLE ENTITLED, ¿THE CORAIL STEM AS A REVERSE HYBRID ¿ SURVIVORSHIP AND X-RAY ANALYSIS AT 10 YEARS¿ BY HELGE WANGEN, ET AL, PUBLISHED BY HIP INTERNATIONAL (2017), DOI: 10.5301/HIPINT.5000477, WAS REVIEWED. THE AUTHORS REPORT THEIR EXPERIENCE OF REVERSE HYBRID THA, USING THE ELITE PLUS POLYETHYLENE CEMENTED CUP TOGETHER WITH THE CORAIL FULLY HYDROXYAPATITE-COATED UNCEMENTED STEM AND A 28-MM ALUMINA CERAMIC HEAD IMPLANTED BETWEEN JANUARY 2000 TO DECEMBER 2003. IMPLANTED PRODUCTS: CORAIL STEM, CHARNLEY ELITE PLUS CUP CEMENTED WITH COMPETITOR CEMENT, AND A 28-MM ALUMINA CERAMIC HEAD BY CERAMTECH. RESULTS: 1 TWO-STAGE REVISION FOR EARLY POSTOPERATIVE INFECTION. 2 EARLY INFECTIONS TREATED WITH SURGICAL DEBRIDEMENT. 2 INFECTIONS TREATED WITH DEBRIDEMENT AND CUP REVISION. 1 HETEROTOPIC OSSIFICATION TREATED WITH EXCISION OF THE HETEROTOPIC BONE AND COMPONENT RETENTION. 1 PERIPROSTHETIC FRACTURE TREATED WITH STEM REVISION. 1 CUP SCHEDULED FOR REVISION DUE TO ASEPTIC LOOSENING. THERE IS INSUFFICIENT INFORMATION WITHIN THE TEXT OF THE ARTICLE TO ATTRIBUTE THE LOOSENING TO THE CUP THAT CEMENTED WITH COMPETITOR CEMENT. 1 CUP LOOSENING DUE TO INFECTION NOT REVISED BECAUSE OF PATIENT REFUSAL. 1 STEM MISPOSITIONED INTO VARUS DUE TO UNDERSIZED STEM. 2 STEMS IDENTIFIED AS TOO SMALL- NOT REVISED. THERE WERE NOTED CASES OF ACETABULAR AND FEMORAL RADIOLUCENT LINES THAT REQUIRED NO INTERVENTION AND WERE NOT PROGRESSIVE. CAPTURED IN THIS COMPLAINT: ELITE PLUS CUP- IMPLANT LOOSENING DUE TO INFECTION; FEMORAL HEAD- NO REPORTED PRODUCT PROBLEM; CORAIL STEM- MISPOSITIONED AND IMPLANT FIT: TOO SMALL. PATIENT HARMS: INFECTION, EXTRASKELETAL OSSIFICATION, FRACTURE POST-OP, SURGICAL INTERVENTION, AND MEDICAL DEVICE REMOVAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143837 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM JDI DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention