BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM -2

    MDR report key: 9293254 · Received November 7, 2019

    Report

    Report Number
    1818910-2019-114934
    Event Type
    Injury
    Date Received
    November 7, 2019
    Date of Event
    April 21, 2015
    Report Date
    October 14, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    UDI-DI
    10603295033899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT.  PATIENT CODE: NO CODE AVAILABLE (3191) USED TO CAPTURE MEDICAL DEVICE REMOVAL AND SURGICAL INTERVENTION PATIENT CODES PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THERE IS NO KNOWN ALLEGATION AGAINST THIS PRODUCT CODE/LOT NUMBER COMBINATION. A COMPLAINT DATABASE SEARCH AND/OR DEVICE MANUFACTURING (DHR) REVIEW WILL NOT BE PERFORMED. IT IS NOT POSSIBLE TO IDENTIFY RELATED REPORTS OR IDENTIFY RELATED ISSUES WITHIN A DHR WHEN THERE IS NO KNOWN PRODUCT ALLEGATION OR ADVERSE PATIENT ISSUE IDENTIFIED. INVESTIGATIONAL INPUTS WERE REQUESTED AS INDICATED PER INTERNAL PROCEDURES FOR THIS FAILURE MODE. THE COMPLAINT INFORMATION PROVIDED HAS BEEN REVIEWED FOR COMPLAINT CODING, MEDICAL DEVICE REPORTING, AND OTHER DATA REQUIRED BY THE COMPLAINT SYSTEM. PER INTERNAL PROCEDURES, THE EVENT INFORMATION AND ANY INVESTIGATIONAL INPUTS RECEIVED AS PART OF REQUIRED FOLLOW UP WERE REVIEWED. FOR THIS INVESTIGATION, NO IMMEDIATE ACTION WAS REQUIRED AS NO ALLEGED DEFICIENCY WITH THE DEVICE WAS IDENTIFIED. - WITHOUT THE PHYSICAL COMPLAINT SAMPLE ASSOCIATED WITH THIS REPORT, IT WAS NOT POSSIBLE TO DETERMINE IF THE DEVICE FAILED TO MEET SPECIFICATIONS AT THE TIME IT WAS RELEASED FOR DISTRIBUTION. - THE DEVICE ASSOCIATED WITH THIS EVENT WAS 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 INDICATED THAT A BROADER INVESTIGATION OR CORRECTIVE ACTION WAS NECESSARY. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PRODUCT COMPLAINT # (B)(4). NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : NULL. DEVICE HISTORY BATCH : NULL. DEVICE HISTORY REVIEW : NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. 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

    PPF AND MEDICAL RECORDS RECEIVED. PPF PROVIDED IMPLANT PRODUCT DETAILS HOWEVER THERE IS NO ALLEGATIONS REPORTED WHILE MEDICAL RECORDS HAS NO REVISION NOTES PROVIDED. THERE WAS NO INDICATION WHY HEAD AND LINER WERE REVISED. SHALL THERE BE NEW INFORMATION RECEIVED THIS COMPLAINT WILL BE UPDATED. DOI; (B)(6) 2007; DOR: (B)(6) 2015; (RIGHT HIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1085292 ARTICULEZE M HEAD 36MM -2 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS JDI DEPUY ORTHOPAEDICS INC US 2280041 10603295033899

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention