BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVS CNTRL 6.5X25MM ST/RST

    MDR report key: 10385276 · Received August 10, 2020

    Report

    Report Number
    0001825034-2020-03098
    Event Type
    Injury
    Date Received
    August 10, 2020
    Date of Event
    February 26, 2020
    Report Date
    August 6, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304677074
    PMA / PMN Number
    K193373
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-01164. DEVICE PRODUCT CODE: PHX. CONCOMITANT MEDICAL DEVICES: PART# 010000589; LOT# 664310; PART# 115395; LOT# 466350; PART# 113652; LOT# 565440; PART# XL-115363; LOT# 596940; PART# 115370; LOT# 632780; PART# 180552; LOT# 339050; PART# 180552; LOT# 819320; PART# 180550; LOT# 961080; PART# 180552; LOT# 035420; PART# 115310; LOT# 669910. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED NO DAMAGE ON THE TAPER ADAPTER. THE BASEPLATE WAS NOT RETURNED FOR EVALUATION. DIMENSIONAL ANALYSIS WAS NOT PERFORMED AS THE TAPER ADAPTER WAS IMPACTED INTO THE BASEPLATE. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: FOUND GLENOSPHERE SITTING IN BASE PLATE DISASSOCIATED, PLATE AND STEM INTACT DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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 A PATIENT UNDERWENT A RIGHT SHOULDER ARTHROPLASTY APPROXIMATELY NINE (9) MONTHS AGO. SUBSEQUENTLY THE PATIENT DISASSOCIATED DURING PT, AND WAS REVISED APPROXIMATELY THREE (3) MONTHS POST PRIMARY IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850850 COMP RVS CNTRL 6.5X25MM ST/RST PROSTHESIS, EXTREMITIES PHX ZIMMER BIOMET, INC. NI 466350 00880304677074

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R