BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M/L TAPER FEMORAL STEM

    MDR report key: 11058450 · Received December 22, 2020

    Report

    Report Number
    0001822565-2020-04206
    Event Type
    Injury
    Date Received
    December 22, 2020
    Date of Event
    September 23, 2020
    Report Date
    August 22, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K032726
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED THROUGH PATIENT'S MEDICAL RECORDS, WHICH CONFIRMS THAT THIS COMPONENT NEEDS REPORTED. THEREFORE, 0001822565-2020-04206-1 DOES NOT APPLY AND THE EVENT REMAINS REPORTABLE FOR THIS COMPONENT. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. D11: ITEM # 00801803201/ HEAD/ LOT # 61350072, ITEM # 00630505032/ LINER/LOT # 61289809, ITEM # 00620005222/ SHELL/ LOT # 61292704, ITEM# 00625006530/BONE SCREW / LOT# 61371953. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2021-00244.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PROPOSED COMPONENT CODE: MECHANICAL (G04)- STEM. ROOT CAUSE REMAINS UNCHANGED. THIS COMPLAINT IS CONFIRMED BASED ON THE PROVIDED MEDICAL RECORDS AND RETURNED DEVICE. 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

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: G3; H2; H3; H6 DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON DUE TO OSTEOARTHRITIS. ZIMMER BIOMET COMPONENTS WERE IMPLANTED WITHOUT COMPLICATIONS. THE PATIENT WAS REVISED ON DUE TO FAILED HIP ARTHROPLASTY. THE PATIENT PRESENTED WITH WORSENING PAIN, THIGH MASS WITH LABS AND IMAGING CONSISTENT WITH CORROSION AND ALTR. DURING THE PROCEDURE, PSEUDOTUMOR/PSEUDOCAPSULE WAS DEBRIDED. THERE WAS BLACK DEBRIS ON THE TRUNNION. PATHOLOGY REPORT REVEALED FRAGMENTS OF NECROTIC TISSUE, AND FIBROADIPOSE TISSUE WITH FOREIGN BODY GIANT CELL REACTION AND PATCHY MIXED INFLAMMATION. THE HEAD AND LINER WERE REPLACED WITH NEW ZIMMER BIOMET PRODUCTS. NO OTHER FINDINGS RELATED TO THE REPORTED EVENT WERE NOTED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THE ADDITIONAL INFORMATION RECEIVED DOES NOT CHANGE THE FINAL CONCLUSIONS OF PREVIOUS INVESTIGATION. 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

    IT WAS FURTHER REPORTED FROM PATIENT'S MEDICAL RECORDS, THAT THE PATIENT UNDERWENT A HIP REVISION FOR PAIN AND ADVERSE LOCATION TISSUE REACTION (ALTR). DURING THE REVISION, PSEUDOCAPSULAR TISSUE WAS DEBRIDED AND TAPER CORROSION WAS NOTED ON THE NECK OF THE FEMORAL STEM. THE HEAD AND LINER WERE REVISED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: PART # UNKNOWN / UNKNOWN HEAD / LOT # UNKNOWN. PART #UNKNOWN / UNKNOWN CUP/ LOT # UNKNOWN. PART #UNKNOWN / UNKNOWN STEM/ LOT # UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2020 -04205.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT RIGHT HIP REVISION APPROXIMATELY TEN YEARS AND 3 MONTHS¿ POST IMPLANTATION FOR UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1522892 M/L TAPER FEMORAL STEM PROSTESIS, HIP LZO ZIMMER BIOMET, INC. NI 61312353
    1522899 M/L TAPER FEMORAL STEM PROSTESIS, HIP LZO ZIMMER BIOMET, INC. NI 61312353

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R SEE H10