BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER HEAD 11/13 36MM +3

    MDR report key: 16817036 · Received April 26, 2023

    Report

    Report Number
    1818910-2023-08767
    Event Type
    Injury
    Date Received
    April 26, 2023
    Date of Event
    March 1, 2023
    Report Date
    April 26, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LZO
    UDI-DI
    10603295033578
    PMA / PMN Number
    P070026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> UPDATE APR 7, 2024 NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A SEARCH OF THE DEPUY NONCONFORMANCE (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT<136536220>/LOT<9180958> COMBINATION. 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 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. _____________________________________________ A SEARCH OF THE DEPUY NONCONFORMANCE (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT<136536220>/LOT<9180958> COMBINATION. H10 ADDITIONAL NARRATIVE: ADDED: B5 D6B AND H6 (IMPACT CODE)

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H6 COMPONENT CODE: APPROPRIATE TERM/CODE NOT AVAILABLE (G07002) USED TO CAPTURE NO FINDINGS AVAILABLE. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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.

    Description of Event or Problem · 0

    A CLINICAL NOTIFICATION UPDATE INDICATES A REVISION WAS COMPLETED ON 22 MAR 2024 TO ADDRESS INFECTION. THE STEM, HEAD, LINER, AND CUP WERE REMOVED.

    Description of Event or Problem · 0

    CLINICAL ADVERSE EVENT RECEIVED FOR DEEP INFECTION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2020, DATE OF EVENT: (B)(6) 2023, (LEFT HIP). TREATMENT: PLAN TO EXPLANT, ADMINISTER ANTIBIOTICS FOR 6 WEEKS, AND RE-PLANT. NO INTERVENTION AS BEEN INITIATED. DEPUY COMPONENTS USED (NO REVISION COMPLETED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465426 DELTA CER HEAD 11/13 36MM +3 S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS LZO DEPUY ORTHOPAEDICS INC US 1365-36-220 9180958 10603295033578

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention ALTRX +4 NEUT 36IDX54OD| DELTA CER HEAD 11/13 36MM +3| PINN CAN BONE SCREW 6.5MMX20MM| PINN CAN BONE SCREW 6.5MMX25MM| PINNACLE SECTOR II CUP 54MM| S-ROM*SLEEVE PRX ZTT, 20D-SML| SROM STM STD 36+12L 15X20