BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BONE CEMENT

    MDR report key: 8268737 · Received January 22, 2019

    Report

    Report Number
    1818910-2019-81842
    Event Type
    Injury
    Date Received
    January 22, 2019
    Report Date
    December 19, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910 
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    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. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT STATES: ¿RECEIVED A REPORT FROM A SALES REP. "I HAVE A CERTAIN WHO HAS HAD, HE SAID SIX PATIENTS NOW THAT HAVE HAD LOOSE PATELLAS AND HE DOESN'T EVEN USE OUR IMPLANT BUT HE HAD USED OUR CEMENT. ... HE SAID ALL 6 PATIENTS WERE AT THE SAME HOSPITAL-WHICH ONLY HAD DEPUY CEMENT AVAILABLE. THE SURGEON HAS SINCE ASKED FOR A COMPETITOR CEMENT TO BE AVAILABLE FOR USE. THE SURGEON SAID HE MIGHT BE ABLE TO GET PART/LOT INFORMATION AND DATES. IF HE IS UNABLE HE WILL REPLY AS SUCH.¿ AS NO SAMPLE OR FURTHER INFORMATION ABOUT THE EVENT IS AVAILABLE, THIS COMPLAINT CANNOT BE CONFIRMED. COMPLAINT INVESTIGATION CONDUCTED BASED ON INFORMATION PROVIDED IN THE COMPLAINT REPORT. NO INVESTIGATIONAL INPUTS WERE RECEIVED. DVA--107020-FDE REV 6 WAS REVIEWED, AND THIS ISSUE IS INCLUDED ON LINES 59-63, 65-67, 69, 173 AND 176. SEE ATTACHMENT ¿EXTRACT FROM DVA-107020-FDE REV 6.PDF¿. IN EACH CASE, THE RISK IS CONSIDERED ¿AS LOW AS POSSIBLE¿ AND CANNOT BE FURTHER MITIGATED. NO INFORMATION RECEIVED WITH THIS INDIVIDUAL COMPLAINT INDICATED THAT A BROADER INVESTIGATION OR CORRECTIVE ACTION WAS NECESSARY. THE NUMBER OF COMPLAINTS RECEIVED FOR THIS FAILURE MODE WILL CONTINUE TO BE MONITORED AND PRODUCT UPDATES/ RECOMMENDATIONS WILL BE IMPLEMENTED AT THE POST MARKET SURVEILLANCE REVIEW DEPENDENT UPON OCCURRENCE RATINGS. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS REQUIRED. DEVICE HISTORY CANNOT BE REVIEWED AS NO LOT OR PRODUCT IDENTIFICATION DETAILS SUPPLIED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH , A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (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

    PATELLA LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61988 UNKNOWN BONE CEMENT BONE CEMENT LOD DEPUY ORTHOPAEDICS, INC. 1818910  UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other