BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM VIT E LINER +0MM

    MDR report key: 14631501 · Received June 8, 2022

    Report

    Report Number
    0001822565-2022-01731
    Event Type
    Injury
    Date Received
    June 8, 2022
    Date of Event
    May 14, 2022
    Report Date
    June 29, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00889024269392
    PMA / PMN Number
    K133378
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMMON DEVICE NAME: DEVICE PRODUCT CODE - PHX. CONCOMITANT MEDICAL PRODUCTS: ITEM# 115310; LOT# J7207291, ITEM# 405889; LOT# 810610, ITEM# 405880; LOT# 531830, ITEM# 110027734; LOT# 937180, ITEM# 110031378; LOT# 937190, ITEM# 180555; LOT# 030310, ITEM# 180555; LOT# 819850, ITEM# 180554; LOT# 161130, ITEM# 180554; LOT# 095380, ITEM# 115399; LOT# 937950. INITIAL REPORTER NAME AND ADDRESS: FULL ESTABLISHMENT NAME - (B)(6) HEALTH CAMPUS. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4; B5; G3; G6; H1; H2; H3; H6. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO PATIENT NONCOMPLIANCE. ACCORDING TO DOCTOR, PATIENT WAS MOWING HIS LAWN AND HAD A HARD JERKING MOTION THAT CAUSED THE DISLOCATION AFTER THE FIRST REVISION. POST OPERATIVELY THE SHOULDER SHOULD BE PROTECTED, IN A SLING UNTIL CLEARED BY THE SURGEON. USING THE ARM TO MOW THE LAWN WITHIN 2 WEEKS POSTOPERATIVELY IS CONSIDERED NONCOMPLIANCE WITH SURGEONS INSTRUCTIONS. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY TWO AND A HALF (2.5) MONTHS POST-IMPLANTATION DUE TO DISLOCATION CAUSED BY OVERACTIVITY. ACCORDING TO THE SURGEON, THE PATIENT WAS MOWING HIS LAWN AND HAD A HARD JERKING MOTION THAT CAUSED THE DISLOCATION. THE GLENOSPHERE WAS UPSIZED AND A NEW RETENTIVE LINER WAS IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    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
    1599918 36MM VIT E LINER +0MM SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. NI 64987742 00889024269392

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Hospitalization| R SEE NARRATIVE IN H10