BEUDAMED
    FDA Adverse Event Injury Summary report: N

    +3MM THICKNESS 40MM DIAMETER BEARING

    MDR report key: 17596599 · Received August 22, 2023

    Report

    Report Number
    0001822565-2023-02248
    Event Type
    Injury
    Date Received
    August 22, 2023
    Date of Event
    August 1, 2023
    Report Date
    January 31, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00887868231599
    PMA / PMN Number
    K181611
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2023-02250-1. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED HUMERAL TRAY AND BEARING ARE STILL ATTACHED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: ON (B)(6) 2023: SINGLE VIEW RIGHT SHOULDER LABELED INITIAL POSTOP DEMONSTRATES RIGHT REVERSE TSA WITH SURGICAL SKIN STAPLES AND SOFT TISSUE AIR CONSISTENT WITH RECENT SURGERY. ON (B)(6) 2023: SINGLE VIEW RIGHT SHOULDER LABELED PRE FIRST REVISION DEMONSTRATES A REVERSE RIGHT TSA WITH INFERIOR DISLOCATION OF THE HUMERAL COMPONENT. ON (B)(6) 2023: SINGLE VIEW RIGHT SHOULDER LABELED POST FIRST REVISION DEMONSTRATES INTACT REVERSE RIGHT TSA ON (B)(6) 2023: SINGLE VIEW RIGHT SHOULDER LABELED POST FIRST REVISION DEMONSTRATES INTACT REVERSE RIGHT TSA. ON (B)(6) 2023: SINGLE VIEW RIGHT SHOULDER LABELED PRE SECOND REVISION DEMONSTRATES A REVERSE RIGHT TSA WITH INFERIOR DISLOCATION OF THE HUMERAL COMPONENT. ON (B)(6) 2023: SINGLE VIEW RIGHT SHOULDER LABELED POST SECOND REVISION DEMONSTRATES INTACT REVERSE RIGHT TSA. RIGHT REVERSE TSA WITH SUBSEQUENT TWICE INFERIOR DISLOCATION OF THE HUMERAL COMPONENT. NO CONTRIBUTING FACTORS SEEN FOR SIGNS OF LOOSENING, WEAR, RADIOLUCENCY, OR MALALIGNMENT THAT WOULD CAUSE ISSUES WITH ANY OF THE COMPONENTS ON THE X-RAY. NO ANATOMICAL OR IMPLANT DEFICIENCIES THAT WOULD CAUSE/CONTRIBUTE TO THE RECURRING INSTABILITY AND NEED FOR REVISION. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2023-02250. D10: MEDICAL PRODUCTS: ITEM#: 110031407, MINI +10MM THICKNESS +6MM TAPER OFFSET 40MM DIAMETER HUMERAL TRAY; LOT#: 64718793. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS REQUESTED FROM THE HOSPITAL BUT NOT RETURNED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY EIGHT (8) MONTHS AGO AND UNDERWENT A REVISION SURGERY THREE (3) MONTHS AFTER THE INITIAL SURGERY DUE TO INSTABILITY. SUBSEQUENTLY, THE PATIENT WAS REVISED A SECOND TIME DUE TO REOCCURRING DISLOCATION OF THE IMPLANTS. THE TRAY AND BEARING WERE EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306922 +3MM THICKNESS 40MM DIAMETER BEARING SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES PHX ZIMMER BIOMET, INC. 65592538 00887868231599

    Patients

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