BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +8.5

    MDR report key: 12278598 · Received August 4, 2021

    Report

    Report Number
    1818910-2021-17081
    Event Type
    Injury
    Date Received
    August 4, 2021
    Date of Event
    July 13, 2021
    Report Date
    July 13, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    UDI-DI
    10603295033950
    PMA / PMN Number
    K980513
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: ADDED: B5 AND H6 (PATIENT). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    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. DEVICE HISTORY LOT: A DEVICE MANUFACTURING (MRE) REVIEW WILL NOT BE PERFORMED EVEN WHEN PRODUCT/LOT INFORMATION IS KNOWN. PER WI-3430 IT HAS BEEN DETERMINED THAT, FOR THE MOM PLATFORM AND RELATED ALLEGATIONS AN MRE IS NOT REQUIRED.

    Description of Event or Problem · 0

    QUESTIONS: A. CAN YOU PLEASE CONFIRM IF THE PATIENT HAD A PREVIOUS REVISION THAT INVOLVES DEPUY PRODUCTS? IF YES, PLEASE PROVIDE PRODUCT DETAILS, OR IF IT WAS PREVIOUSLY REPORTED KINDLY PROVIDE A COMPLAINT NUMBER. B. WE ARE REQUIRED TO ENTER THE FEMORAL STEM INFORMATION WHEN HIGH IONS ARE ALLEGED EVEN IF THE STEM WAS NOT REVISED. CAN YOU PLEASE PROVIDE THE PRODUCT/LOT DETAILS FOR THE STEM? ANSWER: THIS PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2021 FOR THE SAME REASON ON HIS RIGHT SIDE MDR 241445. THIS MDR REFERENCED MISTAKENLY REFERENCES THE RIGHT SIDE AGAIN BUT SHOULD OF BEEN MARKED LEFT SIDE. NO INFORMATION WAS GATHERED ON THE STEM OR CUP. THERE WAS NO PATIENT HARM AND DR PULIDO DECLINED TO GIVE ANY ADDITIONAL INFORMATION. MDR 241445 CAPTURED IN (B)(4) AS PATIENT DEVELOPED A PSEUDO TUMOR IN HIS HIP.

    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 PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY WHERE A SUMMIT STEM WITH A PINNACLE SECTOR CUP WITH AN ULTIMATE METAL LINER WAS USED. THE SURGEON WHO REVISED THIS HIP COULDN¿T RECALL HOW LONG AGO THE PATIENT HAD HIS ORIGINAL SURGERY. BOTH THE STEM AND CUP WERE WELL FIXED. THE SURGEON REMOVED THE LINER AND REPLACED IT WITH A NEUTRAL ALTRX LINER AND A TS CERAMIC HEAD. THE SURGEON STATED PT HAD DEVELOPED ELEVATED METAL ION COUNT. DOI: 2014, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175061 ARTICULEZE M HEAD 36MM +8.5 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS JDI DEPUY ORTHOPAEDICS INC US 1365-53-000 1872583 10603295033950

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR ARTICULEZE M HEAD 36MM +8.5| PINNACLE MTL INS NEUT36IDX52OD| SUMMIT STEM| ARTICULEZE M HEAD 36MM +8.5| PINNACLE MTL INS NEUT36IDX52OD| SUMMIT STEM