BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM PRESS-FIT COLLARLESS STEM CEMENTLESS

    MDR report key: 16284948 · Received February 2, 2023

    Report

    Report Number
    0001822565-2023-00269
    Event Type
    Injury
    Date Received
    February 2, 2023
    Date of Event
    December 19, 2022
    Report Date
    February 21, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00889024139268
    PMA / PMN Number
    K200823
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT: 0001825034-2023-00200, 0001825034-2023-00201, 0001822565-2023-00267, AND 0001822565-2023-00268. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: BONE SCR 6.5X30 SELF-TAP, CAT #: 00625006530, LOT #: J7352161; PRODUCT ID: BONE SCR 6.5X30 SELF-TAP, CAT #: 00625006530, LOT #: J7352156; PRODUCT ID: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, ø 32/-3.5, TAPER 12/14, CAT #: 00877503201, LOT#: 3069804; PRODUCT ID: G7 OSSEOTI MULTIHOLE 50MM D, CAT #: 110010263, LOT #: 65506475; PRODUCT ID: G7 LONGEVITY HIGH WALL 32MM D, CAT #: 20123204, LOT #: 65462155. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2023-00267-1, 0001822565-2023-00268-1. DURING THE INVESTIGATION PROCESS A REVIEW OF THE STERILE CERTIFICATIONS WERE REVIEWED AND FOUND TO BE CONFORMING WITH NO APPLICABLE DEVIATIONS. DEVICES WERE VERIFIED TO HAVE GONE THROUGH ACCEPTABLE STERILIZATION PROCESS FOLLOWING ISO/AAMI/ASTM & EU PUBLISHED GUIDELINES. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE THE CONTROL OF ZIMMER BIOMET, SUCH AS EXTERNAL FACTORS, I.E. HOSPITAL/SURGICAL ENVIRONMENT, PROVIDER RELATED RISK FACTORS, AND/OR PATIENT COMORBIDITIES/RISK FACTORS. AS THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUES IDENTIFIED AFFECTING IMPLANT SAFETY OR EFFECTIVENESS, IMPLANTED PRODUCTS ARE NOT IDENTIFIED AS THE SOURCE OR CONTRIBUTING TO THE REPORTED INFECTION. A HEMATOMA IS A MASS OF CLOTTED BLOOD THAT FORMS IN A TISSUE, ORGAN, OR BODY SPACE. A HEMATOMA CAN BE ASSOCIATED WITH PAIN, SWELLING, ECCHYMOSIS, SEROSANGUINOUS OR BLOODY DRAINAGE AFTER A RECENT SURGICAL PROCEDURE OR TRAUMA AND CAN PREDISPOSE THE PATIENT TO INFECTION. THE DEVELOPMENT OF A POSTOPERATIVE HEMATOMA CAN BE CORRELATED WITH THE SURGICAL PROCEDURE AND PERIOPERATIVE ANTICOAGULATION THERAPY PRESCRIBED TO PREVENT THROMBUS FORMATION. MOST HEMATOMAS RESOLVE ON THEIR OWN, WITHOUT SURGICAL INTERVENTION, WHILE SOME DO NOT. LARGER HEMATOMAS MAY NEED TO BE SURGICALLY EVACUATED IN ORDER TO RESOLVE. AS TIMEFRAMES OF ONSET DIFFER DUE TO INDIVIDUAL CONTRIBUTING FACTORS, A SPECIFIC TIMEFRAME OF EXPECTED OCCURRENCE CANNOT BE ESTABLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY ONE MONTH POST IMPLANTATION DUE TO A POST-OP HEMATOMA AND DRAINING SINUS. THIS REQUIRED AN INCISION, DRAINAGE, ANTIBIOTICS AND JOINT DEBRIDEMENT. CONCLUDING THIS PROCEDURE, AN UNSPECIFIED INFECTION WAS NOTED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY ONE MONTH POST IMPLANTATION DUE TO A POST-OP HEMATOMA AND DRAINING SINUS. THIS REQUIRED AN INCISION, DRAINAGE, ANTIBIOTICS AND JOINT DEBRIDEMENT. CONCLUDING THIS PROCEDURE, AN UNSPECIFIED INFECTION WAS NOTED. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS. APPROXIMATELY A MONTH LATER THE PATIENT EXPERIENCE CONTINUED WOUND DRAINAGE AND SIGNS OF AN INFECTION. THE PATIENT WAS COVID POSITIVE AND UNDERWENT A SECOND IRRIGATION AND DEBRIDEMENT ALONG WITH REPLACEMENT OF THE HEAD AND LINER. CULTURES FROM THIS REVISION SURGERY WERE POSITIVE FOR INFECTION AND PATIENT CONTINUED IV ANTIBIOTICS ALONG WITH FOLLOW UP CARE FROM AN INFECTIOUS DISEASE SPECIALIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389412 FEMORAL STEM PRESS-FIT COLLARLESS STEM CEMENTLESS PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. NI 65603489 00889024139268

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Other| H SEE H10.