BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS SHLDR GLNSP STD 36MM

    MDR report key: 12369952 · Received August 26, 2021

    Report

    Report Number
    0001825034-2021-02438
    Event Type
    Injury
    Date Received
    August 26, 2021
    Date of Event
    August 9, 2019
    Report Date
    September 30, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    K080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT 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. 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 CORRECTED: H6: THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H6, H11. H6: PROPOSED G-CODE: MECHANICAL (G04) HEAD. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: REVISION OP REPORT: PERSISTENT PAIN. PRE-OP DIAGNOSIS OF LEFT SHOULDER DRAINING AXILLARY CYST WITH PRESUMED INFECTION NO POSITIVE CULTURES WERE PROVIDED, OR DOCUMENTATION OF INFECTION RESULTS. ADHESIONS RELEASED, AND IMPLANTS WERE FOUND WELL FIXED. REMOVED ALL HARDWARE AND TWO SUTURE ANCHORS, I&D. EXPOSED GLENOID BASE PLATE. CENTRAL AND PERIPHERAL SCREWS WERE REMOVED; INFERIOR AND ANTERIOR WERE STRIPPED. ANOTHER SURGEON, ALONG WITH ADDITIONAL CUTTERS, OSEOTEOMES UNSUCCESSFUL, WITH FINAL TREPHINE TO REMOVE REMNANT SCREWS, NO INDICATION OF RFB. EXPLORATION OF AXILLARY CYST/WOUND, 4CMX4CM, EXCISED DRAINING SINUS, PLACED DRAIN DUE TO LOCATION IN AXILLARY AND CONCERNS WITH HEALING, WOUND CLOSED. NOTES ¿AXILLARY WOUND DID PROBE DEEP TO BONE AND SHOULDER JOINT¿. FINAL PLACEMENT ANTIBIOTIC CEMENT SPACER CREATED AND PLACED INTO HUMERUS. PATH REPORT: SYNOVIAL TISSUE ACUTE & CHRONIC INFLAMMATION. UPON CONCLUSION OF THE INVESTIGATION, NO PROBLEM WAS FOUND WITH THE GIVEN DEVICE. THE REPORTED EVENT IS CONFIRMED, HOWEVER, IT IS UNRELATED TO THE REPORTED PRODUCTS. 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

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE DUE TO AN AXILLARY CYST THAT WAS FOUND THAT COMMUNICATED TO BONE/JOINT. ALL HARDWARE WAS REMOVED. IRRIGATION AND DEBRIDEMENT OF JOINT SPACE AND CYST WITH CEMENT SPACER & DRAINS WERE PLACED. DURING THE PROCEDURE SURGEON HAD DIFFICULTY REMOVING 2 STRIPPED SCREWS, BUT WERE EXPLANTED WITHOUT INDICATION OF RETAINED PRODUCTS.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT CODE: PHX CONCOMITANT MEDICAL PRODUCTS: 115370 COMP RVS TRAY 987730. XL-115363 HMRL BRNG 083700. 115330 COMP RVRS SHDR GLEN BSPLT 550170. 113651 COMP PRIMARY STEM 658090. 118001 COMP TI STD TAPER 022770. 180553 COMP LK SCR 3.5HEX 586200. 180509 COMP NON-LCKNG SCREW 931620. 180503 COMP LOCKING SCREW 120540. 180503 COMP LOCKING SCREW 424160. 115382 COMP RVS CNTRL SCR 714480. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2021 - 02436. 0001825034 - 2021 - 02437. 0001825034 - 2021 - 02439. 0001825034 - 2021 - 02440. 0001825034 - 2021 - 02441. 0001825034 - 2021 - 02442. 0001825034 - 2021 - 02443. 0001825034 - 2021 - 02444. 0001825034 - 2021 - 02445. 0001825034 - 2021 - 02446.

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENTS¿ LEGAL COUNSEL THAT THE PATIENT UNDERWENT A LEFT TOTAL SHOULDER ARTHROPLASTY REVISION PROCEDURE APPROXIMATELY SIX (6) YEARS POST-IMPLANTATION DUE TO PAIN, LOSS OF RANGE OF MOTION, AND LOOSENING OF THE COMPONENTS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1267912 COMP RVRS SHLDR GLNSP STD 36MM PROSTHESIS, SHOULDER PHX ZIMMER BIOMET, INC. N/A 036770

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H10.