BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP BALL BIOLOX 32 +5 12/14

    MDR report key: 19733595 · Received July 12, 2024

    Report

    Report Number
    1818910-2024-14964
    Event Type
    Injury
    Date Received
    July 12, 2024
    Date of Event
    April 18, 2016
    Report Date
    July 12, 2024
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    LPH
    UDI-DI
    10603295359159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4) E3: THE INITIAL REPORTER HAS BEEN REMOVED FOR CONFIDENTIALITY/PRIVACY. THE INITIAL REPORTER IS THE PATIENT. INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. VISUAL EXAMINATION OF THE RETURNED DEVICE ALONG WITH PHOTOGRAPHIC EVIDENCE DID NOT IDENTIFY A DEVICE ISSUE. IT CANNOT BE DETERMINED THAT A DEVICE FAILURE OR MALFUNCTION CONTRIBUTED TO REPORTED EVENT. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. PATIENT CONTACTED DPS CUSTOMER SERVICE. HE RECEIVED HIP-TEP RIGHT SIDE ON (B)(6) 2016. REVISION OF HIP HEAD AND INLAY AT UNKNOWN DATE IN UNKNOWN HOSPITAL. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. THE DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. VISUAL EXAMINATION OF THE RETURNED DEVICE ALONG WITH PHOTOGRAPHIC EVIDENCE DID NOT IDENTIFY A DEVICE ISSUE. IT CANNOT BE DETERMINED THAT A DEVICE FAILURE OR MALFUNCTION CONTRIBUTED TO REPORTED EVENT. WEAR MARKS WERE OBSERVED THROUGH THE FEMORAL HEAD SURFACE, HOWEVER, THESE WERE EXTRACTION DAMAGES AND DID NOT SIGNIFY ANY PRODUCT ERROR. A DHR WAS PERFORMED: 1) QUANTITY MANUFACTURED: 20 PARTS 2) DATE OF MANUFACTURE: 19/JAN/2016 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NONE 4) EXPIRY DATE: 31/DEC/2021 5) IFU REFERENCE: 090200701 AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THERE IS NO REPORTED ALLEGATION ON 9111132/HIP BALL BIOLOX 32 +5 12/14THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DRAWING/SPECIFICATIONS REVIEWED? N/A DIMENSIONAL INSPECTION: N/A DEVICE HISTORY LOT A DHR WAS PERFORMED: 1) QUANTITY MANUFACTURED: (B)(4) PARTS 2) DATE OF MANUFACTURE: 19/JAN/2016 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NONE 4) EXPIRY DATE: 31/DEC/2021 5) IFU REFERENCE: 090200701 DEVICE HISTORY REVIEW A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE (9111132/8242960) PRODUCT AND LOT NUMBERS, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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.

    Description of Event or Problem · 0

    PATIENT CONTACTED DPS CUSTOMER SERVICE. HE RECEIVED HIP-TEP RIGHT SIDE ON (B)(6) 2016. REVISION OF HIP HEAD AND INLAY AT UNKNOWN DATE IN UNKNOWN HOSPITAL. UPDATED EVENT DESCRIPTION: THE PATIENT WAS REVISED DUE TO LUXATION. DOI: ON (B)(6) 2016. DOR: UNKNOWN. RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979730 HIP BALL BIOLOX 32 +5 12/14 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS LPH DEPUY INTERNATIONAL LTD - 8010379 8242960 10603295359159

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention APEX HOLE ELIM POSITIVE STOP| CORAIL2 STD SIZE 9| PINN MAR +4 NEUT 32IDX54OD| PINNACLE 100 ACET CUP 54MM