BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP BALL BIOLOX 32 +1 12/14

    MDR report key: 16395750 · Received February 17, 2023

    Report

    Report Number
    1818910-2023-03946
    Event Type
    Injury
    Date Received
    February 17, 2023
    Date of Event
    February 1, 2023
    Report Date
    February 17, 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 FOUND THE IMPLANT WITH A WORN APPEARANCE CONSISTENT WITH MATERIAL TRANSFER FROM THE INNER SURFACE OF THE CUP AS A RESULT OF A DISASSOCIATION OF THE ACETABULAR LINER FROM THE CUP. THE OBSERVED APPEARANCE IS NOT INDICATIVE OF A DEVICE NONCONFORMANCE. IT WOULD NOT BE UNREASONABLE THAT AN AUDIBLE NOISE WOULD BE GENERATED FROM ARTICULATION OF THE FEMORAL HEAD AGAINST THE CUP POST DISASSOCIATION OF THE LINER. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT ==> DHR DETAILS FOR PRODUCT NAME: HIP BALL BIOLOX 32 +1 12/1, PRODUCT CODE:9111131,LOT:9256292. 1) QUANTITY MANUFACTURED: 20. 2) DATE OF MANUFACTURE: 08-19-2019. 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NO NON-CONFORMANCE WERE IDENTIFIED. 4) EXPIRY DATE: 07-31-2024. 5) IFU REFERENCE: 090200701. DEVICE HISTORY REVIEW ==> A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [9111131 /9256292] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    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.

    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). 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. DEVICE HISTORY LOT: DHR DETAILS FOR PRODUCT NAME: HIP BALL BIOLOX 32 +1 12/1, PRODUCT CODE:9111131,LOT:9256292. 1) QUANTITY MANUFACTURED: (B)(4). 2) DATE OF MANUFACTURE: 08-19-2019. 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NO NON-CONFORMANCE WERE IDENTIFIED. 4) EXPIRY DATE: 07-31-2024. 5) IFU REFERENCE: 090200701.

    Description of Event or Problem · 0

    SURGEON GAVE A CALL DIRECTLY TO COMPLAINT HANDLING UNIT: IMPLANTATION OF HIP-TEP RIGHT SIDE ON (B)(6) 2019. REVISION OF INLAY AND HIP HEAD ON (B)(6) 2023 AS INLAY DISASSOCIATED FROM CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135138 HIP BALL BIOLOX 32 +1 12/14 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS LPH DEPUY INTERNATIONAL LTD - 8010379 9256292

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention HIP BALL BIOLOX 32 +1 12/14.| PINN MAR +4 10D 32IDX52OD.| PINNACLE 100 ACET CUP 52MM.