BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER FM HD 032/-4.0 12/14

    MDR report key: 11272623 · Received February 3, 2021

    Report

    Report Number
    3002806535-2021-00032
    Event Type
    Injury
    Date Received
    February 3, 2021
    Date of Event
    October 15, 2020
    Report Date
    April 6, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 002806535-2021-00029-1, 3002806535-2021-00030-1, 3002806535-2021-00031-1. THE PRODUCTS HAVE NOT BEEN RECEIVED: THEREFORE THE CONDITION OF THE COMPONENTS ARE UNKNOWN. IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO AN INFECTION ONSET 6 YEARS 9 MONTHS POST-OP. THE STERILISATION CERTIFICATES WERE REVIEWED AND CONFIRMED THAT PRODUCT IS STERILISED WITHIN THE SPECIFICATION RANGE. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND NO SIMILAR COMPLAINTS REPORTED WITH THE ITEM NUMBERS 123952, 650-0791, 650-0955 AND 650-0833. MEDICAL NOTES WERE PROVIDED WHICH CONFIRM THAT PATIENT UNDERWENT A REVISION DUE TO INFECTION. THE LEFT HIP SHOWS PARTLY CHRONICALLY GRANULATION TISSUE AND PARTLY WEAR-INDUCED TYPE 1 SYNOVITIS/NEOSYNOVITIS. NO EVIDENCE OF MALIGNANCY. NO BACTERIA WAS DETECTED AT THE TIME OF THE REVISION SURGERY. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. SINGLE-USE, STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER BIOMET ARE STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL OF 1.0 X 10-6 OR BETTER. THEREFORE, IT IS UNLIKELY THAT THE SPECIFIED DEVICE CAUSED ANY PATIENT INFECTION. RISK ASSESSMENT: ROOT CAUSE: RISK MANAGEMENT REPORT DOCUMENTS THE ESTIMATED RESIDUAL RISK ASSOCIATED WITH EXCEED ABT. THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION, THEREFORE THE SPECIFIC FAILURE CAUSE WITHIN THE RISK TABLES COULD NOT BE SELECTED FOR COMPARISON. BETWEEN 22 JANUARY 2018 AND 22 JANUARY 2021 NUMBER OF SIMILAR INCIDENTS IDENTIFIED: 1 OCCURRENCE RATE ASSESSMENT 22 JANUARY 2018 AND 22 JANUARY 2021, 1664 ITEMS SOLD THE GIVEN PERIOD. OCCURRENCE RATIO: 1:1,664 RISK STATEMENT: THE REPORTED EVENT STATES THAT THE REVISION WAS PERFORMED DUE TO INFECTION. USING EXCEED ABT FINAL RISK MANAGEMENT REPORT THE CALCULATED RISK IS AS FOLLOWS, SEVERITY OF THE REPORTED EVENT = S-1 (NO ADVERSE HEALTH CONSEQUENCE) AND CALCULATED OCCURRENCE RATE OF P-2 (RARE - UNLIKELY TO OCCUR) ARE IN LINE WITH THE RISK FILE. THEREFORE, THE OVERALL SCORE AND RISK LEVEL IS DEEMED AS NEGLIGIBLE H3 OTHER TEXT : PRODUCT NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL LEFT HIP ARTHROPLASTY ON (B)(6) 2014. SUBSEQUENTLY, THE PATIENT SUFFERED TO AN INFECTION (SEPSIS) WHICH RESULTED IN A SPACER IMPLANTATION IN LEFT HIP. THE REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2020. FOLLOWING THE REVISION SURGERY, IT WAS OBSERVED THAT PATIENT SHOWED ALLERGIC REACTION TO NICKEL AND COBALT. THE REVISED PRODUCTS WERE NOT ZIMMER BIOMET DEVICES.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CONCOMITANT MEDICAL PRODUCT: MEDICAL PRODUCT: EXCEED ABT 3HL SHELL 39/52MM, CATALOG #: 123952, LOT #: 3148012; MEDICAL PRODUCT: BIOLOX DELTA LNR 32MM 50-52MM, CATALOG #: 650-0791, LOT #: 3195905; MEDICAL PRODUCT: MICRO TLOC STD PC 11MM (12/14), CATALOG #: 650-0955, LOT #: 2988636. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00029, 3002806535-2021-00030, 3002806535-2021-00031. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD AN INITIAL SURGERY (LEFT SIDE) ON (B)(6) 2014. SUBSEQUENTLY, ON (B)(6) 2020 THE PATIENT UNDERWENT A REVISION SURGERY, DUE TO INFECTION/ALLERGY. IT WAS ALSO OBSERVED THAT THE PATIENT SHOWED ALLERGIC REACTION TO NICKEL AND COBALT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169009 DELTA CER FM HD 032/-4.0 12/14 HIP ARTHROPLASTY LPH BIOMET UK LTD. N/A 3185710

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R