BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERCHANGEABLE HUMERAL ASSEMBLY FOR CEMENTED USE ONLY SMALL

    MDR report key: 15275801 · Received August 23, 2022

    Report

    Report Number
    0001822565-2022-02435
    Event Type
    Injury
    Date Received
    August 23, 2022
    Date of Event
    July 13, 2022
    Report Date
    December 29, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDC
    UDI-DI
    00889024508590
    PMA / PMN Number
    K001989
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-01884. CONCOMITANT MEDICAL PRODUCTS: ITEM#: 32810504302, PT HYBRID GLEN POST REGENEREX; LOT#: 964350, ITEM#: 32810502501, C/M PIN/BUSHING REV KIT, SMALL/REGULAR HUMERUS; LOT#: 64584581, ITEM#: 00888700200, BACTISURE WOUND LAVAGE WW, LOT#: Q2105392. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS PRODUCT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6: COMPONENT CODES: MECHANICAL (G04) - STEM NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: RIGHT ELBOW ARTHROPLASTY IMPLANTS ARE PRESENT WITHOUT FRACTURE OR DISLOCATION. THERE IS MILD ANGULATION OF THE HUMERAL AND ULNAR ALIGNMENT ON THE AP VIEW WITHOUT FRANK MALALIGNMENT. THERE IS NO EVIDENCE OF IMPLANT LOOSENING OR OTHER ABNORMALITY. THE IMPLANT FIT IS MAINTAINED. BONE QUALITY IS OSTEOPENIC. THERE IS REGIONAL SOFT TISSUE SWELLING AND A SMALL AMOUNT OF ANTERIOR JOINT LINE HETEROTOPIC OSSIFICATION. TIMELINE REVIEWS WERE PROVIDED AND REVIEWED IDENTIFYING THE FOLLOWING: (B)(6), 2022 OFFICE VISIT -- SYMPTOMS PERSISTED DESPITE OT FOR STRENGTHENING-CURRENT PAIN LEVEL 7/10. THE PATIENT COMPLAINED OF CONSTANT RADIATING PAIN (TO FOREARM) WITH ACTIVITIES AND AT NIGHT. THE PATIENT WAS TAKING OPIOID PAIN MEDICATION. SWELLING WAS PRESENT, AND THE PATIENT NOTED SQUEAKING OF THE JOINT WITH ROM. 3 X-RAYS WERE COMPLETED: RETAINED SUTURE ANCHOR IN THE LATERAL COLUMN OF THE DISTAL HUMERUS; CHRONIC CHANGES WERE NOTED BUT NO APPARENT LOOSENING OF THE ULNAR OR HUMERAL COMPONENTS; APPEARANCE OF ASYMMETRIC WEAR OF THE POLYETHYLENE; AND POTENTIAL METAL-ON-METAL CONTACT. REVISION SURGERY TO REVISE THE BUSHING AND POLYETHYLENE RECOMMENDED, ULNAR AND HUMERAL COMPONENTS WERE FELT TO BE STABLE. (B)(6), 2022 REVISION SURGERY -- GENERAL ANESTHESIA WITH REGIONAL BLOCK, EBL 25ML. SIGNIFICANT SCAR TISSUE WAS ENCOUNTERED AND CAREFULLY RESECTED. HETEROTOPIC BONE WAS REMOVED ABOUT THE ELBOW JOINT. THE HUMERAL AND ULNAR COMPONENTS WERE NOT LOOSE, THEY DEMONSTRATED SECURE FIXATION. SIGNIFICANT DAMAGE TO THE POLYETHYLENE, AT LEAST ONE AREA WAS COMPLETELY ERODED. METALLOSIS WAS NOTED ABOUT THE JOINT AND WAS CAREFULLY DEBRIDED. NEW COMPONENTS WERE PLACED WITHOUT ISSUE. ZIMMER BIOMET BACTISURE WOUND LAVAGE WAS UTILIZED. THE ELBOW HAD FULL ROM AT COMPLETION OF THE PROCEDURE. NO INTRA-OP COMPLICATIONS WERE NOTED. THE PATIENT WAS TRANSFERRED TO PACU IN STABLE CONDITION AND DISCHARGED HOME THE SAME DAY. PLAN: ROUTINE FOLLOW-UP IN ABOUT 2 WEEKS POST-OP. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL RIGHT TOTAL ELBOW ELEVEN (11) YEARS AND THREE (3) MONTHS AND HAD STARTED TO EXPERIENCE PAIN, SWELLING, AND A SQUEAKING NOISE. SUBSEQUENTLY, THE PATIENT UNDERWENT A RIGHT ELBOW REVISION SURGERY DUE TO IMPLANT FAILURE DUE TO IMPLANT WEAR AND METALLOSIS. DURING THE PROCEDURE, THE SURGEON NOTED CHRONIC CHANGES, SCAR TISSUE AND HETEROTOPIC BONE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2851626 INTERCHANGEABLE HUMERAL ASSEMBLY FOR CEMENTED USE ONLY SMALL PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED/EXTREMITIES JDC ZIMMER BIOMET, INC. 32-8105-25-04 61635055 00889024508590

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H SEE H10 NARRATIVE