BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE HUMERAL TI TRAY 44MM

    MDR report key: 7046033 · Received November 20, 2017

    Report

    Report Number
    0001825034-2017-10439
    Event Type
    Injury
    Date Received
    November 20, 2017
    Date of Event
    March 30, 2017
    Report Date
    September 17, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    Z-1103-2017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIONAL NOTES, AS WELL AS PHOTOGRAPHS. INVESTIGATION RESULTS REMAIN 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 · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE STEM HAD FRACTURED FROM THE MAIN BODY WITH THE STEM SHOWING A WEAR LINE NEAR THE FRACTURE SITE. 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 · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 · 1

    (B)(4). CONCOMITANT PRODUCTS: 115330, COMP RVRS SHDR GLEN BSPLT +HA, 881220. 118001, VERSA-DIAL/COMP TI STD TAPER, 925500. 115310, COMP RVRS SHLDR GLNSP STD 36MM, 508640. 113635, COMP PRIMARY STEM 15MM MINI, 508750. XL-115364, ARCOM XL 44-36 STD +3 HMRL BRG, 349410. 115383, COMP RVS CNTRL SCR 6.5X35MM ST, 666640. 180500, COMP LOCKING SCREW 4.75X15MM, 340500. 180500, COMP LOCKING SCREW 4.75X15MM, 513510. 180503, COMP LOCKING SCREW 4.75X30MM, 069260. 180502, COMP LOCKING SCREW 4.75X25MM, 340580. 405800, COMP. REV SHLDR 9 IN STEINMANN, 025050. 405889, COMP RVS 2.7MM DIA DRL, 506540. 405883, COMP RVS 3.2MM DRL, 976380. 32-486265, 1/8 QUICK REL DRL STERILE 2PK, 408700. CUSTOMER HAS BEEN INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED EVENT COULD NOT BE CONFIRMED BASED ON LIMITED INFORMATION RECEIVED. NO PRODUCTS WERE RETURNED; THEREFORE, THE VISUAL AND DIMENSIONAL INSPECTIONS WERE NOT PERFORMED. DEVICE HISTORY RECORD (DHR) REVIEW DETERMINED THERE WERE NO DEVIATIONS. INVESTIGATION DETERMINED THAT THE ROOT CAUSE IS CONSIDERED TO BE A PREVIOUSLY ADDRESSED DESIGN ISSUE, AND THAT THIS DEVICE IS IN SCOPE OF A PREVIOUS RECALL FOR THIS REPORTED ISSUE. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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 · 1

    (B)(4). THE FOLLOWING REPORT IS SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT¿S LEGAL COUNSEL THAT THE PATIENT UNDERWENT RIGHT TOTAL SHOULDER ARTHROPLASTY. THE LEGAL COUNSEL FURTHER REPORTS THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO PATIENT ALLEGATIONS OF PAIN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT¿S LEGAL COUNSEL THAT THE PATIENT UNDERWENT RIGHT TOTAL SHOULDER ARTHROPLASTY. THE LEGAL COUNSEL FURTHER REPORTS THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO PATIENT ALLEGATIONS OF A LOUD POP, LEADING TO SUBSEQUENT PAIN. RADIOGRAPHS REVEALED A FRACTURED HUMERAL TRAY COMPONENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824667 COMPREHENSIVE REVERSE HUMERAL TI TRAY 44MM PROSTHESIS, SHOULDER PAO ZIMMER BIOMET, INC. N/A 118380

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R