BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI ACETABULAR SHELL MULTI HOLE

    MDR report key: 8566586 · Received April 30, 2019

    Report

    Report Number
    0001825034-2019-01829
    Event Type
    Injury
    Date Received
    April 30, 2019
    Date of Event
    April 6, 2019
    Report Date
    May 14, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K140669
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING : LOOSENING OF THE ACETABULAR CUP FROM RIGHT TOTAL HIP ARTHROPLASTY WITHOUT DISLOCATION WAS NOTED. NO OTHER ANOMALIES WERE IDENTIFIED. NO FURTHER EVALUATION WAS POSSIBLE WITH THE IMAGES PROVIDED. 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 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: PART: 110024464, G7 DUAL MOBILITY LINER 44MM F, LOT: 166300. PART: EP-200150, ACT ARTIC E1 HIP BRG 28X44MM, LOT: 820730. PART: 00801802802, FEMORAL HEAD STERILE PRODUCT 12/14 TAPER, LOT: 64156841. PART: 010000996, G7 SCREW, LOT: 6456735. PART: 010000996, G7 SCREW, LOT: 6352938. PART: 010000997, G7 SCREW, LOT: 6329780. PART: 010000999, G7 SCREW, LOT: 6478743. PART: 31-323220, RINGLOC + ACETABULAR DRILL BIT, LOT: 182840. PART: 31-323240, RINGLOC + ACETABULAR DRILL BIT, LOT: 951390. PART: 013593, SMITH AND NEPHEW SUTURE RETRIEVER, LOT: 2018785. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE WAS REQUESTED BUT NOT RETURNED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT HIP PROCEDURE AND SUBSEQUENTLY, WAS REVISED ONE WEEK LATER DUE TO CUP LOOSENING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359920 G7 OSSEOTI ACETABULAR SHELL MULTI HOLE PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6453028

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R