BEUDAMED
    FDA Adverse Event Death Summary report: N

    BI-POLAR 28 CUP 55MM

    MDR report key: 8482192 · Received April 4, 2019

    Report

    Report Number
    3002806535-2019-00348
    Event Type
    Death
    Date Received
    April 4, 2019
    Date of Event
    January 20, 2019
    Report Date
    June 18, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D4: UDI: (B)(4). G3: REPORT SOURCE, FOREIGN: EVENT OCCURRED IN POLAND. D11: MEDICAL PRODUCT: TPRLC COCR 10X140MM 12/14, CATALOG#: 650-0338, LOT#: 6395452. MEDICAL PRODUCT: DELTA CER FM HD 028/0MM 12/14, CATALOG#: 650-0831, LOT#: 2018032021. MEDICAL PRODUCT: REFOBACIN BONE CEMENT R 1X40-3, CATALOG#: 3003940001-3, LOT#: 815AAK0709. MEDICAL PRODUCT: OPTIVAC M, CATALOG#: 4160, LOT#: 0001316296. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00347-1, 3002806535-2019-00349-1. PRODUCTS HAVE BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION AND FORWARDED TO A RESEARCH ENGINEER FOR INVESTIGATION. SUMMARY OF INVESTIGATION: DISCUSSION: A TAPERLOC COCR STEM WITH A J-HOOK STEM EXTRACTOR STILL ATTACHED WAS RECEIVED FOR EXAMINATION. THE STEM WAS REVISED AFTER 2 MONTHS AND 24 DAYS. AS DESCRIBED IN THE COMPLAINT DESCRIPTION, LOOSENING WAS INITIALLY SUSPECTED AS THE REASON FOR REVISION. HOWEVER, AFTER RECEIVING FURTHER INFORMATION FROM THE SURGEON IT WAS ESTABLISHED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO SEPSIS. THE SURGEON DECIDED TO REMOVE THE IMPLANT IN AN ATTEMPT TO CURE THE SEPSIS. MOREOVER, THE COMPLAINT DESCRIPTION STATES THAT: WHEN THE PATIENT WAS REVISED THERE WAS ABSOLUTELY NO INDICATION THAT THE IMPLANT COULD IN ANY WAY CONTRIBUTE TO THE STATE OF THE PATIENT (THERE WAS NO SIGNS OF INFECTION, LOOSENING OR OTHER PROBLEMS AROUND THE IMPLANT). THE IMPLANT WAS REMOVED AND REPLACED WITH SPACER (EVEN THOUGH THERE WAS NO EVIDENCE THAT THE IMPLANT HAD ANY NEGATIVE EFFECT). VISUAL EXAMINATION OF THE STEM INDICATES AN OVERALL GOOD CONDITION. MINOR DAMAGES OBSERVED ON THE COMPONENT WERE LIKELY CAUSED BY THE EXTRACTION PROCEDURE AND THE CONTACT OF THE STEM WITH THE J-HOOK EXTRACTOR. SURGICAL REPORTS AND RADIOGRAPHS FROM THE PRIMARY AND REVISION SURGERY HAVE NOT BEEN PROVIDED FOR REVIEW. ADDITIONALLY, PATIENT INFORMATION SUCH AS AGE, HEIGHT, AND WEIGHT HAVE NOT BEEN PROVIDED DUE TO COUNTRY REGULATIONS. REVIEW OF THE DEVICE MHRS CONFIRMED THAT THE STEM HAD BEEN MANUFACTURED AND STERILISED CORRECTLY. NO EVIDENCE WAS FOUND THAT THE TAPERLOC STEM MALFUNCTIONED DURING USE OR THAT IT COULD HAVE CAUSED THE REPORTED SEPSIS IN THIS PATIENT. CONCLUSION: A TAPERLOC COCR CEMENTED STEM WAS REVISED AFTER 2 MONTHS AND 24 DAYS. THE ANALYSIS OF THE RETURNED STEM WITH A J-HOOK EXTRACTOR DID NOT FIND ANY EVIDENCE THAT THE TAPERLOC STEM MALFUNCTIONED DURING USE OR THAT IT COULD HAVE CAUSED THE REPORTED SEPSIS. RISK ASSESSMENT: FROM THIS INFORMATION, ROOT CAUSE CANNOT BE CONFIRMED AND THE COMPLAINT INDICATES THAT HARM WAS NOT RELATED TO THE DEVICE, THEREFORE, A RISK ASSESSMENT CANNOT BE PERFORMED BASED ON THE INFORMATION PROVIDED. CORRECTIVE AND PREVENTIVE ACTIOS TAKEN: NO ACTIONS NEEDED AT THIS TIME. THIS COMPLAINT WAS DETERMINED NOT TO BE A NEW CONFIRMED QUALITY OR MANUFACTURING ISSUE. COMPLAINTS ARE MONITORED THROUGH MONTHLY COMPLAINT REVIEW (REFERENCE: (B)(4) IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. 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 HAS BEEN REPORTED BY THE HOSPITAL THAT A PATIENT UNDERWENT AN INITIAL HIP REPLACEMENT SURGERY. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2019 DUE TO FEMORAL STEM LOOSENING (REPORTED UNDER REF: 3002806535-2019-00110) AT DIFFERENT HOSPITAL. FURTHER INFORMATION WAS RECEIVED REPORTING THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH SEPSIS. DURING INVESTIGATION FOR THE REASON OF SEPSIS THE SURGEON FOUND OUT THAT THE PATIENT HAD A HIP IMPLANT, AND ASSUMED THIS COULD BE THE CAUSE OF THE INFECTION. THE SURGEON DECIDED TO REMOVE THE IMPLANT IN ORDER TO CURE THE SEPSIS. HOWEVER, WHEN THE PATIENT WAS REVISED THERE WAS NO INDICATION THAT THE IMPLANT COULD IN ANY WAY CONTRIBUTE TO THE STATE OF THE PATIENT. THE HOSPITAL REPORTED THAT THE PATIENT DIED 2 DAYS AFTER THE REVISION SURGERY.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: TPRLC COCR 10X140MM 12/14, ITEM NO: 650-0338, LOT NO: 6395452; MEDICAL PRODUCT: DELTA CER FM HD 028/0MM 12/14, ITEM NO: 650-0831, LOT NO: 2018032021; MEDICAL PRODUCT: REFOBACIN BONE CEMENT R 1X40-3, ITEM NO: 3003940001-3, LOT NO: 815AAK0709; MEDICAL PRODUCT: OPTIVAC M, ITEM NO: 4160, LOT NO: 0001316296. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00347, 3002806535-2019-00349. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED BY THE HOSPITAL THAT A PATIENT UNDERWENT AN INITIAL HIP REPLACEMENT SURGERY . SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2019 DUE TO FEMORAL STEM LOOSENING (REPORTED UNDER REF: 3002806535-2019-00110) AT DIFFERENT HOSPITAL. FURTHER INFORMATION WAS RECEIVED REPORTING THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH SEPSIS. DURING INVESTIGATION FOR THE REASON OF SEPSIS THE SURGEON FOUND OUT THAT THE PATIENT HAD A HIP IMPLANT, AND ASSUMED THIS COULD BE THE CAUSE OF THE INFECTION. THE SURGEON DECIDED TO REMOVE THE IMPLANT IN ORDER TO CURE THE SEPSIS. HOWEVER, WHEN THE PATIENT WAS REVISED THERE WAS NO INDICATION THAT THE IMPLANT COULD IN ANY WAY CONTRIBUTE TO THE STATE OF THE PATIENT. THE HOSPITAL REPORTED THAT THE PATIENT DIED 2 DAYS AFTER THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278731 BI-POLAR 28 CUP 55MM HIP PROSTHESIS LPH BIOMET UK LTD. N/A 6170954

    Patients

    Seq Age Sex Outcome Treatment
    1 Death