BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 NEU +5MM E1 LINER

    MDR report key: 9804959 · Received March 9, 2020

    Report

    Report Number
    0001825034-2020-01034
    Event Type
    Injury
    Date Received
    March 9, 2020
    Date of Event
    February 11, 2020
    Report Date
    June 23, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K142882
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF PHOTOS WERE PROVIDED SHOWED ONE PHOTO OF A CERAMIC HEAD WITH BLOOD AND NO OTHER DISTINGUISHING FACTORS CAN BE SEEN.TWO PHOTOS OF WHAT APPEARS TO BE THE RIM OF THE LINER AND ANOTHER PHOTO OF THAT PIECE WITH A LINER THAT IS BLOODIED AND SHOWS MISSING PIECE. NOTHING DISTINGUISHABLE CAN BE IDENTIFIED.ONE PHOTO IS OF THE BLOODIED LINER WITH THE MISSING RIM AND MAJOR DAMAGE OF THE LINER. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED TWO VIEWS OF THE RIGHT HIP DEMONSTRATE A RIGHT TOTAL HIP ARTHROPLASTY WITH SCREW FIXATION OF THE ACETABULAR CUP. ACETABULAR CUP APPEARS TO BE SMALL AS COMPARED OF THE FEMORAL HEAD SIZE. NO RADIOLUCENCY. NO FRACTURE SEEN. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE ROOT CAUSE OF THE REPORTED EVENT WAS 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). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED CONCOMITANT MEDICAL PRODUCTS: ITEM # 010001001/ BONE SCREW / LOT # 6161767. ITEM# 110010262/ G7 MULTIHOLE SHELL/ LOT # 3983120. ITEM# 00625006520 /BONE SCREW/LOT # 63862349. ITEM# 51-104110/ TRPLC STEM/ LOT # 6143203. ITEM# 12-115116 / BIOLOXD HEAD/ / LOT # 540280.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT RIGHT HIP REVISION SURGERY APPROXIMATELY 2 YEARS POST IMPLANTATION DUE TO INSTABILITY AND LINER FRACTURE. PATIENT REPORTED CLUNKING NOISE 3 MONTHS PRIOR TO REVISION WHICH INCREASINGLY GOT WORSE. PATIENT DID NOT DESCRIBE A FALL OR IMPACT TO LEG. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269978 G7 NEU +5MM E1 LINER PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. NI 3509943

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R