BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURON 10D 50OD X 28ID

    MDR report key: 14515633 · Received May 26, 2022

    Report

    Report Number
    1818910-2022-09699
    Event Type
    Injury
    Date Received
    May 26, 2022
    Date of Event
    June 1, 2022
    Report Date
    May 26, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    K900832
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    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. DEVICE HISTORY LOT: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. AFTER SURGERY, WEAR OF THE LINER WAS CONFIRMED. ON (B)(6), 2022, THE ACETABULAR IMPLANT AND INNER HEAD WILL BE REPLACED IN A REVISION SURGERY. THE STEM WILL BE KEPT USING AS IT IS. THE SALES REP IS NOW CHECKING THE DETAILS. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2000.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2022. THE REVISION SURGERY WITH THE TOTAL HIP ARTHROPLASTY WAS PERFORMED ON (B)(6) 2022. DURING THE REVISION SURGERY, WHEN THE SURGEON REMOVED THE INNER HEAD, BLACK RING WAS FOUND ON BOTH MATING PARTS OF THE STEM AND THE HEAD. UNEVEN WEAR AND OXIDATION DISCOLORATION WAS FOUND ON THE LINER SLIDING SURFACES. AFTER REMOVAL OF THE CUP, THE ZB¿S AVANTAGE WAS USED FOR THE ACETABULUM SIDE. ALTHOUGH THE SALES REP EXPLAINED REGARDING THE RISKS OF USING DELTA CERAMIC HEAD, THE SURGEON FIRMLY REQUESTED TO USE THE DELTA CERAMIC HEAD. THEREFORE, THE DELTA CERAMIC HEAD WAS USED AS INNER HEAD UNDER THE SURGEON¿S RESPONSIBILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711442 ENDURON 10D 50OD X 28ID DURALOC IMPLANT : HIP POLY ACETABULAR LINERS JDI DEPUY ORTHOPAEDICS INC US WMM-25

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention 9/10 COCR HEAD 28MM +3| AML A PLUS 12.0 MM| DURALOC 1200 SERIES 50MM OD