BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP BALL BIOLOX 32 +1 12/14

    MDR report key: 16361540 · Received February 13, 2023

    Report

    Report Number
    1818910-2023-03483
    Event Type
    Injury
    Date Received
    February 13, 2023
    Date of Event
    January 10, 2023
    Report Date
    February 13, 2023
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : THE DEVICE ASSOCIATED WITH THIS REPORT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL EXAMINATION OF THE DEVICE CONFIRM THE REPORTED ALLEGATION. THE FEMORAL HEAD SHOWED A SMALL DARK AREA OF TRANSFERRED TITANIUM AS A RESULT OF ARTICULATING DIRECTLY AGAINST THE ACETABULAR CUP DUE TO A DISASSOCIATION BETWEEN THE LINER AND THE CUP. IT IS REASONABLE TO CONCLUDE THAT THE DIRECT ARTICULATION BETWEEN THE FEMORAL HEAD AND ACETABULAR CUP COULD HAVE RESULTED IN AN AUDIBLE NOISE. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT : 1) QUANTITY MANUFACTURED: (B)(4). 2) DATE OF MANUFACTURE: 25-JAN-2021 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. 4) EXPIRY DATE: 31-DEC-2025 5) IFU REFERENCE: 090200701 IFU TOT HIP PROS. DEVICE HISTORY REVIEW : A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [9111131 / 9686949] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING MANUFACTURING.

    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). 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). 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED. INDICATED, THAT THERE WAS NO SURGICAL DELAY REPORTED. THE PATIENT NOTICED, "CRACKING" AT THE AREA OF THE RIGHT HIP, SINCE ABOUT 4 MONTHS. THE PAIN EXTENDS TO THE SPINE. NO KNOWN TRAUMA, AFTER IMPLANTATION OF A RIGHT HIP.

    Description of Event or Problem · 0

    SURGEON SENT AN EMAIL DIRECTLY TO COMPLAINT HANDLING UNIT: HE REPORTED ABOUT AN MARATHON INALY DAMAGE . REVISION OF INLAY COMPONENT ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1387962 HIP BALL BIOLOX 32 +1 12/14 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS LPH DEPUY INTERNATIONAL LTD - 8010379 9686949

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention APEX HOLE ELIM POSITIVE STOP| APEX HOLE ELIMINATOR-PS| BIOLOX FORTE CERAMIC HEAD D32MM +1| CORAIL HIP SYSTEM CEMENTLESS HA COATET 12/14 AMT| CORAIL2 STD SIZE 10| PINN 100 W/GRIPTION 48MM| PINN MAR +4 10D 32IDX48OD| PINN MAR +4 10D 32IDX48OD