BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR NECK X1 12/14 NECK TAPER USE WITH +0 HEADS ONLY

    MDR report key: 10083459 · Received May 22, 2020

    Report

    Report Number
    0001822565-2020-01713
    Event Type
    Injury
    Date Received
    May 22, 2020
    Date of Event
    March 11, 2020
    Report Date
    February 16, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K182678
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D11: ZIMMER TRILOGY ACETABULAR SYSTEM SHELL WITH CLUSTER HOLES (REF. 00-6200-064-22, LOT NO. 61269969). ZIMMER TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE LINER (REF. 00-6305-064-40, LOT NO. 61754345). ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV MODULAR FEMORAL STEM (REF. 65-7713-012-00, LOT NO. 61767676). ZIMMER VERSYS HIP SYSTEM FEMORAL HEAD (REF. 00-8018-040-02, LOT NO. 61866236). ZIMMER KINECTIV TECHNOLOGY MODULAR NECK (REF. 00-7848-014-01, LOT NO. 61540982). ZIMMER BONE SCREW (REF. 00-6250-065-35, LOT NO. 61869003). ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED WITH MEDICAL RECORDS PROVIDED. PHOTOGRAPHS OF THE IMPLANTED STEM AND THE EXPLANTED PRODUCTS WERE PROVIDED. VISUAL REVIEW IDENTIFIED THE FOLLOWING: THE EXPLANTED HEAD AND LINER WERE COVERED IN BIODEBRIS. THE FEMORAL HEAD'S TAPER SURFACE WAS DISCOLORED, AND THE LINER WAS FRACTURED. NO FURTHER EVALUATION WAS POSSIBLE WITH THE IMAGES PROVIDED. RADIOGRAPHS WERE PROVIDED BUT NOT REVIEWED AS IT WAS DETERMINED BY THE HEALTH CARE PROFESSIONAL THAT METAL RELATED PATHOLOGY CANNOT BE SEEN ON AN X RAY. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED; UPDATED: D8; H2; H3; H6. REPORTED EVENT WAS CONFIRMED WITH MEDICAL RECORDS PROVIDED. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO FAILED HIP ARTHROPLASTY. DURING THE REVISION PROCEDURE, PSEUDOTUMOR WAS PRESENT IN THE JOINT CAPSULE. CORROSION AT THE HEAD-NECK JUNCTION. THE SURGEON WAS NOT ABLE TO DISENGAGE THE NECK FROM THE STEM. THERE WAS THIN LAYER OF REACTIVE SOFT TISSUE INSIDE THE SHELL. NO OTHER COMPLICATIONS/FINDINGS RELATED TO THE EVENT WERE NOTED. PHOTOGRAPHS OF THE IMPLANTED STEM AND THE EXPLANTED PRODUCTS WERE PROVIDED. VISUAL REVIEW IDENTIFIED THE FOLLOWING: THE EXPLANTED HEAD AND LINER WERE COVERED IN BIODEBRIS. THE FEMORAL HEAD'S TAPER SURFACE WAS DISCOLORED, AND THE LINER WAS FRACTURED. NO FURTHER EVALUATION WAS POSSIBLE WITH THE IMAGES PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE DEVICE REMAINS IMPLANTED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0002648920-2020-00265.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LEFT TOTAL HIP REPLACEMENT APPROXIMATELY 9 YEARS AGO. SUBSEQUENTLY, PATIENT WAS REVISED DUE TO PAIN, PSEUDOTUMOR, AND ELEVATED METAL ION LEVELS. THE LINER WAS DAMAGED UPON REMOVAL. THE HEAD AND LINER WERE REPLACED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547410 MODULAR NECK X1 12/14 NECK TAPER USE WITH +0 HEADS ONLY PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 61540982

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R UNKNOWN CUP| UNKNOWN ZIMMER M/L TAPER KINECTIV STEM, LOT # UNK| ZIMMER HEAD CAT#00801804002 LOT#61865236| ZIMMER LINER CAT#00-6305-064-40, LOT#UNK| UNKNOWN CUP| UNKNOWN ZIMMER M/L TAPER KINECTIV STEM, LOT # UNK| ZIMMER HEAD CAT#00801804002 LOT#61865236| ZIMMER LINER CAT#00-6305-064-40, LOT#UNK