BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP BALL BIOLOX 32 +1 12/14

    MDR report key: 19384406 · Received May 23, 2024

    Report

    Report Number
    1818910-2024-10987
    Event Type
    Injury
    Date Received
    May 23, 2024
    Date of Event
    April 13, 2022
    Report Date
    May 17, 2024
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    LPH
    PMA / PMN Number
    OUS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H6 COMPONENT CODE: APPROPRIATE TERM/CODE NOT AVAILABLE (G07002) USED TO CAPTURE NO FINDINGS AVAILABLE. E3 INITIAL REPORTER OCCUPATION: LAWYER. INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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 RECORDS EVALUATION (MRE) WAS NOT PERFORM 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. 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. PRODUCT DESCRIPTION:- HIP BALL BIOLOX 32 +1 12/14. PRODUCT CODE:- 9111131. LOT NO:- 9535212. QUANTITY OF MANUFACTURED:- (B)(4). DATE OF MANUFACTURING:- 28-MAY-2020. EXPIRY DATE:- 30-APR-2025. 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: PRODUCT DESCRIPTION:- HIP BALL BIOLOX 32 +1 12/14. PRODUCT CODE:- 9111131. LOT NO:- 9535212. QUANTITY OF MANUFACTURED:- (B)(4). DATE OF MANUFACTURING:- 28-MAY-2020. EXPIRY DATE:- 30-APR-2025. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    Description of Event or Problem · 0

    PATIENT LAWYER IS CLAIMING FOR COMPENSATION. THE PATIENT WAS IMPLANTED ON THE LEFT SIDE A TOTAL ENDOPROSTHESIS IN THE LEFT HIP JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2054667 HIP BALL BIOLOX 32 +1 12/14 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS LPH DEPUY INTERNATIONAL LTD - 8010379 9535212

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention APEX HOLE ELIM POSITIVE STOP| CORAIL2 STD SIZE 10| PINN MAR +4 10D 32IDX50OD| PINNACLE 100 ACET CUP 50MM