BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVACIT-E DM LINER 28 X 38MM

    MDR report key: 10501764 · Received September 8, 2020

    Report

    Report Number
    0001822565-2020-03177
    Event Type
    Injury
    Date Received
    September 8, 2020
    Date of Event
    September 1, 2020
    Report Date
    September 15, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024572676
    PMA / PMN Number
    K190656
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: A1; A2; A3; B1; B2; B3; B5; D7; D11; G4; H1; H2; H3; H6. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO A MANUFACTURING DEFICIENCY. A CORRECTIVE ACTION WAS INITIATED FOR FURTHER INVESTIGATION AND ROOT CAUSE DETERMINATION. 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

    IT WAS REPORTED THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 2 MONTHS POST-IMPLANTATION DUE TO THE WRONG SIZE IMPLANT BEING IMPLANTED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: 110010242- G7 OSSEOTI 3 HOLE SHELL 48MM C- 6768309; 110024461- G7 DUAL MOBILITY LINER 38MM C- 838550; 51-105150- TPRLC XR T1 PPS 15X150MM- 3406258; 010000998- G7 SCREW 6.5MM X 25MM- 6690498; 010000999- G7 SCREW 6.5MM X 30MM- 6736389; 010000997- G7 SCREW 6.5MM X 20MM- 6633152; 12-115111- CER BIOLOXD MOD HD 28MM +3 NK- 2971501. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING TOTAL HIP ARTHROPLASTY THE WRONG SIZE IMPLANT WAS IN THE BOX AND IMPLANTED. THE SURGEON WILL CONSULT WITH THE PATIENT ON BEST COURSE OF ACTION FORWARD. THE PROCEDURE HAD A 5-MINUTE DELAY, MOST DUE TO WHAT THEY THOUGHT WAS WORKING SOFT TISSUE OUT OF THE WAY OF THE BEARING. NO EFFECT ON THE PATIENT DUE TO DELAY. 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
    967725 VIVACIT-E DM LINER 28 X 38MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 64755636 00889024572676

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10