BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS SHLDR GLNSP STD 36MM

    MDR report key: 14631499 · Received June 8, 2022

    Report

    Report Number
    0001825034-2022-01372
    Event Type
    Injury
    Date Received
    June 8, 2022
    Date of Event
    May 14, 2022
    Report Date
    June 21, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304475373
    PMA / PMN Number
    K193373
    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). DEVICE PRODUCT CODE: PHX. CONCOMITANT MEDICAL PRODUCTS: ITEM# 00435003600; LOT# 64987742, 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. FULL ESTABLISHMENT NAME: (B)(4). 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. PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY TWO AND A HALF (2.5) WEEKS POST-SURGERY DUE TO DISLOCATION CAUSED BY OVERACTIVITY. 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
    1599917 COMP RVRS SHLDR GLNSP STD 36MM SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. NI J7207291 00880304475373

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention| H SEE NARRATIVE IN H10