BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS 25MM BSPLT HA+ADPTR

    MDR report key: 9847880 · Received March 18, 2020

    Report

    Report Number
    0001825034-2020-01164
    Event Type
    Injury
    Date Received
    March 18, 2020
    Date of Event
    February 26, 2020
    Report Date
    August 6, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304532465
    PMA / PMN Number
    K120121
    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 · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-03098 THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; D6; D11; G4; G7; H1; H2; H3; H6 D2: DEVICE PRODUCT CODE: PHX D6: IMPLANT DATE CORRECTED TO (B)(6)2019. D11: PART# 115395; LOT# 466350 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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: COMP RVS TRAY CO 44MM ; PART# 115370 ; LOT#63278, ARCOM XL 44-36 STD HMRL BRNG ; PART# XL-115363 ; LOT# 596940, COMP RVS CNTRL 6.5X25MM ST/RST ; PART# 115395 ; LOT# 46363, COMP RVRS SHLDR GLNSP STD 36MM ; PART# 115310 ; LOT# 669910. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT SHOULDER ARTHROPLASTY SUBSEQUENTLY THE PATIENT DISASSOCIATED DURING PT SOMETIME BETWEEN TEN (10) AND ELEVEN (11) MONTHS POST-OP, AND WAS REVISED APPROXIMATELY ONE (1) YEAR AND ONE (1) 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
    311189 COMP RVRS 25MM BSPLT HA+ADPTR PROSTHESIS, EXTREMITIES KWS ZIMMER BIOMET, INC. NI 664310 00880304532465

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R SEE NARRATIVE IN H10