BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP PRIMARY STEM 8MM MINI

    MDR report key: 12143804 · Received July 9, 2021

    Report

    Report Number
    0001825034-2021-02027
    Event Type
    Injury
    Date Received
    July 9, 2021
    Date of Event
    September 3, 2019
    Report Date
    May 31, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    UDI-DI
    00887868267758
    PMA / PMN Number
    K193038
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    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: 0001825034-2021-02025-1, 0001825034-2021-02026-1. INVESTIGATION REMAINS UNCHANGED. 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) THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-02025-2 THE FOLLOWING SECTIONS WERE UPDATED: A2; B4; B5; B6; D1; D2; D4; D6; D9; D10; G1-2; G3; G4; G6; H1; H2; H3; H4 D10: MEDICAL PRODUCTS: ITEM#: 115310, COMP RVRS SHLDR GLNSP STD 36MM; LOT#: 555040 ITEM#: 110031418, BEARING STANDARD 36 MM DIAMETER; LOT#: 64299880 H6: COMPONENT CODE: MECHANICAL (G04) - STEM NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. 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: A REVERSE-TYPE LEFT SHOULDER ARTHROPLASTY IS PRESENT. THE GLENOID IMPLANT APPEARS UNREMARKABLE. THERE IS SUBLUXATION OF THE HUMERAL IMPLANT WITH WIDENING OF THE PROSTHETIC GLENOHUMERAL SPACE SEEN ON THE AP VIEW. THERE IS ALSO A MILDLY DISPLACED FRACTURE OF THE PROXIMAL HUMERUS OF UNCERTAIN ACUITY WITH PROXIMAL HUMERAL CERCLAGE WIRE FIXATION. BONE QUALITY IS OSTEOPENIC. IT REMAINS THAT 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

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-02025, 0001825034-2021-02026. MEDICAL PRODUCTS: ITEM#: UNKNOWN, EXT-COMPREHENSIVE-GLENOSPHERE-UNK; LOT#: UNKNOWN. ITEM#: UNKNOWN, EXT-BEARING-HUMERAL BEARING-UNK; LOT#: UNKNOWN. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. MEDICAL RECORDS WERE NOT PROVIDED. 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 · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY APPROXIMATELY EIGHTEEN (18) YEARS AGO FOR UNKNOWN REASON. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY TWO (2) YEARS AGO. THE PATIENT UNDERWENT A SECOND REVISION APPROXIMATELY THREE (3) MONTHS AFTER FIRST REVISION DUE TO PROSTHESIS SUBLUXATION AND TUBEROSITY FRACTURE OF THEIR HUMERAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039511 COMP PRIMARY STEM 8MM MINI PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED MBF ZIMMER BIOMET, INC. N/A 092560 00887868267758
    1039515 COMP PRIMARY STEM 8MM MINI PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED MBF ZIMMER BIOMET, INC. N/A 092560 00887868267758

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Hospitalization| R SEE H10 NARRATIVE.| SEE H10 NARRATIVE.