BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP BALL BIOLOX 32 +5 12/14

    MDR report key: 13060598 · Received December 22, 2021

    Report

    Report Number
    1818910-2021-28679
    Event Type
    Injury
    Date Received
    December 22, 2021
    Date of Event
    October 29, 2021
    Report Date
    January 26, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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). 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 : BFARM DHR REVIEW. PRODUCT CODE: 9111132. LOT: 8050959. PRODUCT DESCRIPTION: HIP BALL BIOLOX 32 +5 12/14. 1) QUANTITY MANUFACTURED: (B)(4). 2) DATE OF MANUFACTURE: 14-JANUARY-2015. 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. 4) EXPIRY DATE: 31 DECEMBER 2019. 5) IFU REFERENCE: 090200701 CORRECTED: G1.

    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 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. H10 ADDITIONAL NARRATIVE: 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

    REVISION OF HIP COMPONENT(S). DOI: 2015, DOR: 2021.

    Description of Event or Problem · 0

    AFTER REVIEW OF MEDICAL RECORDS, ON (B)(6) 2015, THE PATIENT UNDERWENT A PRIMARY LEFT HIP ARTHROPLASTY WITH IMPLANTATION OF DEPUY FEMORAL STEM AND FEMORAL HEAD ALONG WITH COMPETITOR ACETABULAR CUP AND ACETABULAR LINER. ENDOPLANT GMBH INSERT WAS REVISED TOGETHER WITH DEPUY PRODUCTS ON (B)(6) 2015, THE PATIENT UNDERWENT A FIRST LEFT HIP REVISION TO ADDRESS INFECTION, REDNESS, AND NECROSIS. THE DEPUY FEMORAL HEAD AND COMPETITOR LINER WERE REVISED. THE DEPUY FEMORAL STEM AND COMPETITOR ACETABULAR LINER WERE RETAINED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1964731 HIP BALL BIOLOX 32 +5 12/14 HIP FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US 8050959

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Unknown Required Intervention COMPETITOR CUP| ENDOPLANT GMBH INSERT| HIP BALL BIOLOX 32 +5 12/14| UNKNOWN HIP FEMORAL STEM| UNKNOWN HIP IMPLANT