BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +1.5

    MDR report key: 9912504 · Received April 1, 2020

    Report

    Report Number
    1818910-2020-09949
    Event Type
    Injury
    Date Received
    April 1, 2020
    Date of Event
    January 31, 2016
    Report Date
    March 16, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    UDI-DI
    10603295033912
    PMA / PMN Number
    K980513
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT: (B)(4). 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.

    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: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. 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.

    Description of Event or Problem · 0

    UPDATE AD (B)(6) 2020: ADDITIONAL INFORMATION RECEIVED. FOLLOW-UP MEDICAL RECORD REVIEW (A-4031578), AS A CONTINUATION OF THE INVESTIGATION INITIATED IN A-(B)(6), IDENTIFIED IN THE MEDICAL RECORDS THAT THE REVISING SURGEON OFFERED NO DEFINITIVE CONCLUSIONS BEYOND THE REPORTED UNEVEN POLYETHYLENE WEAR OF THE ACETABULAR LINER. WHILE SUGGESTING POSSIBLE IMPINGEMENT AS THE CAUSE PRE-OPERATIVELY AND IMMEDIATELY POST-OPERATIVELY, HE EVENTUALLY MAKES THE STATEMENT THERE WAS WEAR SUPERIORLY ON THE LINER, AND SUGGESTS IT CAME FROM THE NECK, BUT GOES ON TO INDICATE THAT THERE WAS ABSOLUTELY NO REPRODUCIBLE IMPINGEMENT. THERE WAS ALSO NO REASON OFFERED TO EXPLAIN THE OBSERVED PRE-OPERATIVE SQUEAKING. HE ALSO INDICATED THAT THE PATIENT WAS VERY HEAVY WHICH MAY HAVE CONTRIBUTED IN SOME MANNER TO THE UNEVEN WEAR. REVIEW WITH THE PRODUCT ANALYST DETERMINED THAT THE STEM AND CUP WERE THE ONLY REASONABLE SOURCES FOR THE SQUEAKING, GIVEN THAT THERE WAS NO CUP-LINER DISASSOCIATION.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. 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

    PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORD RECEIVED. AFTER REVIEW OF MEDICAL RECORD THE PATIENT WAS REVISED TO ADDRESS PAIN, IMPINGEMENT, DISLODGEMENT, SQUEAKING AND POLY WEAR. REVISION NOTES STATED THAT THERE WAS DENSE AMOUNT OF SCAR. THERE WAS NO FLUID AND EVIDENCE OF INFECTION. IT WAS STATED THAT THERE WERE NO IMPINGEMENT OR REASON THAT THIS SHOULD SHIFT OR MOVE. THERE IS WEAR FROM THE NECK ASYMMETRICALLY ON THE SUPERIOR PORTION OF THE CUP. DOI: (B)(6) 2016. DOR: (B)(6) 2016, (LEFT HIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375221 ARTICULEZE M HEAD 36MM +1.5 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS JDI DEPUY ORTHOPAEDICS INC US 1365-51-000 8374664 10603295033912

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention ALTRX NEUT 36IDX54OD| APEX HOLE ELIM POSITIVE STOP| CORAIL2 STD SIZE 11| PINNACLE 100 ACET CUP 54MM