BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEVANEY RT TRIFLANGE SZ24X54

    MDR report key: 6883292 · Received September 21, 2017

    Report

    Report Number
    0001825034-2017-07038
    Event Type
    Injury
    Date Received
    September 21, 2017
    Date of Event
    September 6, 2017
    Report Date
    January 25, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING REPORT IS SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: REACH 15X200 100% POR FMRL STR LOT#999570 ITEM#12-162115, 36 MM COCR MOD HD STD LOT#805010 ITEM#11-363662, TI LOW PROFILE SCREW 6.5 X 50 MM LOT#956570 ITEM#103537, R/C II CONSTRAINED LINER SZ 24 LOT#958240 ITEM#11-107004, TI LOW PROFILE SCREW 6.5 X 20 MM LOT#220350 ITEM#103531, TI LOW PROFILE SCREW 6.5 X 25 MM LOT#618880 ITEM#103532, TI LOW PROFILE SCREW 6.5 X 25 MM LOT#097050 ITEM#103532, TI LOW PROFILE SCREW 6.5 X 25 MM LOT#104440 ITEM#103532, TI LOW PROFILE SCREW 6.5 X 25 MM LOT#163690 ITEM#103532, TI LOW PROFILE SCREW 6.5 X 25 MM LOT#027100 ITEM#103532, TI LOW PROFILE SCREW 6.5 X 25 MM LOT#189220 ITEM#103532, TI LOW PROFILE SCREW 6.5 X 30 MM LOT#097180 ITEM#103533, TI LOW PROFILE SCREW 6.5 X 35 MM LOT#902930 ITEM#103534, TI LOW PROFILE SCREW 6.5 X 35 MM LOT#845550 ITEM#103534, TI LOW PROFILE SCREW 6.5 X 35 MM LOT#253360 ITEM#103534, TI LOW PROFILE SCREW 6.5 X 35 MM LOT#476980 ITEM#103534, TI LOW PROFILE SCREW 6.5 X 40 MM LOT#155870, ITEM#103535, TI LOW PROFILE SCREW 6.5 X 40 MM LOT#155870 ITEM#103535. THE REPORTED EVENT COULD NOT BE CONFIRMED BASED ON LIMITED INFORMATION RECEIVED. NO PRODUCTS WERE RETURNED; THEREFORE, THE VISUAL AND DIMENSIONAL INSPECTIONS WERE NOT PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. . A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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 · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. (B)(4). 11-107004, R/C II CONSTRAINED LINER SZ 24, 958240.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO LOOSENING. 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
    664556 DEVANEY RT TRIFLANGE SZ24X54 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 771180

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R