BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK CEMENT ENDURANCE

    MDR report key: 19258574 · Received May 7, 2024

    Report

    Report Number
    1818910-2024-10007
    Event Type
    Injury
    Date Received
    May 7, 2024
    Date of Event
    May 29, 2023
    Report Date
    May 7, 2024
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). D4: THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, 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. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT/LOT NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A¿DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED. TOYODA T, OE K, IIDA H, NAKAMURA T, OKAMOTO N, SAITO T. TREATMENT STRATEGIES FOR RECURRENT DISLOCATION FOLLOWING TOTAL HIP ARTHROPLASTY: RELATIONSHIP BETWEEN CAUSE OF DISLOCATION AND TYPE OF REVISION SURGERY. BMC MUSCULOSKELET DISORD. 2023 MAR 29;24(1):238. DOI: 10.1186/S12891-023-06355-4. PMID: 36991409; PMCID: PMC10053790. THE AIM OF THIS STUDY WAS TO EVALUATE THE RESULTS OF REVISION SURGERY FOR DISLOCATED HIPS. 71 HIPS WERE INCLUDED WITHIN THE STUDY. ALL PATIENTS HAD UNDERGONE AN OPERATION FOR DISLOCATION. IMPLANTS INVOLVED IN THE DISLOCATION EVENTS AREN¿T NOTED WITHIN THE ARTICLE. THE PATIENTS WERE BROKEN UP INTO 7 GROUPS BASED OFF TREATMENT FOR THE DISLOCATION. GROUP A, OPEN REDUCTION AND INTERNAL FIXATION (ORIF); GROUP B, HEAD CHANGE OR LINER CHANGE ONLY; GROUP C, CUP CHANGE WITH INCREASED HEAD SIZE ONLY; GROUP D, STEM CHANGE ONLY; GROUP E, CUP AND STEM CHANGE; AND GROUP F, CONVERSION TO CONSTRAINED CUP. C-STEM WAS USED IN 8/35 FEMORAL STEM REVISIONS. ENDURANCE BONE CEMENT WAS USED IN ALL COMPONENTS. ALL OTHER COMPONENTS PLACED AT REVISION WERE EITHER COMPETITOR OR NOT MENTIONED WITHIN THE ARTICLE. THE LITERATURE ARTICLE DOES NOT PROVIDE SUFFICIENT INFORMATION TO ASSOCIATED SPECIFIC ADVERSE EVENTS WITH SPECIFIC DEVICE MANUFACTURERS FOR THE NOTED DISLOCATIONS OR IMPLANT BREAKAGE. 5 PATIENTS UNDERWENT REPEAT REVISION SURGERIES FOR DISLOCATION (CAPTURED IN TABLE 3) 3 PATIENTS UNDERWENT REPEAT REVISION SURGERIES FOR INFECTION. 1 PATIENT UNDERWENT REPEAT REVISION SURGERIES FOR IMPLANT BREAKAGE. ADVERSE EVENT(S) POSSIBLY ASSOCIATED WITH ENDURANCE BONE CEMENT 3 PATIENTS UNDERWENT REPEAT REVISION SURGERIES FOR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671606 UNK CEMENT ENDURANCE BONE CEMENT LOD DEPUY IRELAND - 3015516266

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention