BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA CER HEAD 12/14 36MM +8.5

    MDR report key: 10043541 · Received May 11, 2020

    Report

    Report Number
    1818910-2020-11934
    Event Type
    Malfunction
    Date Received
    May 11, 2020
    Date of Event
    May 5, 2020
    Report Date
    May 5, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LZO
    UDI-DI
    10603295033639
    PMA / PMN Number
    K031803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> EXAMINATION OF THE RETURNED PACKAGE CONFIRMS THE REPORTED ALLEGATION. NO PROCESSING/PACKAGING ERROR BY DEPUY WAS IDENTIFIED. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT ==> LOT 9242791 A REVIEW OF THE MANUFACTURING RECORDS (MRE) FOUND NO RELATED DEVIATIONS OR ANOMALIES. DEVICE HISTORY REVIEW ==> A REVIEW OF THE MANUFACTURING RECORDS (MRE) FOUND NO RELATED DEVIATIONS OR ANOMALIES.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : EXAMINATION OF THE RETURNED PACKAGE CONFIRMS THE REPORTED ALLEGATION. NO PROCESSING/PACKAGING ERROR BY DEPUY WAS IDENTIFIED. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : LOT 9242791 A REVIEW OF THE MANUFACTURING RECORDS (MRE) FOUND NO RELATED DEVIATIONS OR ANOMALIES. DEVICE HISTORY REVIEW : A REVIEW OF THE MANUFACTURING RECORDS (MRE) FOUND NO RELATED DEVIATIONS OR ANOMALIES.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED THAT THE EVENT HAPPENED DURING PRIMARY SURGERY. NO HARM OR DELAY AND WAS SUCCESSFULLY IMPLANTED.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKAGING FOR BIOLOX HEAD WAS FAULTY. TOP LAYER RIPPED SO NURSE HAD TO HANDLE THE INNER PACKAGING AND OPEN THE FEMORAL HEAD DIRECTLY TO THE FIELD. THE PADDING WAS STUCK TO THE INNER COVER AS WELL SO SURGICAL SCRUB HAD TO REACH IN AND GRAB HEAD DIRECTLY. I HAVE SAVED ALL THE PACKAGING IF ANYONE AT DEPUY WOULD LIKE TO SEE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506763 DELTA CER HEAD 12/14 36MM +8.5 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS LZO DEPUY ORTHOPAEDICS INC US 1365-36-330 9242791 10603295033639

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male