BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER

    MDR report key: 9660651 · Received February 3, 2020

    Report

    Report Number
    0002648920-2020-00046
    Event Type
    Injury
    Date Received
    February 3, 2020
    Date of Event
    September 26, 2016
    Report Date
    March 20, 2020
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    PMA / PMN Number
    K953337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. MEDICAL RECORDS IDENTIFIED THE FOLLOWING: FIVE YEARS POST IMPLANTATION PATIENT PRESENTED WITH PAIN AND ELEVATED METAL ION LEVELS. MRI RESULTS WERE CONSISTENT WITH EXTENSIVE CORROSION AT THE HEAD/TAPER JUNCTION AND PSEUDOTUMOR. THERE WAS EVIDENCE OF METAL DEBRIS, ABDUCTOR MUSCLE NECROSIS AND CAPSULAR TISSUE NECROSIS. PATIENT UNDERWENT A REVISION SURGERY: THE STEM AND SHELL WERE WELL-FIXED AND LEFT IN PLACE, HEAD AND LINER WERE REPLACED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ZIMMER TRILOGY ACETABULAR SHELL, CAT. NO. 00-6200-052-22, LOT NO. 60987950, ZIMMER TRILOGY LONGEVITY CROSSLINKED LINER, CAT. NO. 00-6305-050-32, LOT NO. 61100560, VERSYS FIBER METAL TAPER STEM, CAT. NO. 00-7862-014-00, LOT NO. 61195257. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2019 - 02419.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED TRUNNIONOSIS WITH METALLOSIS AND ABDUCTOR MUSCLE NECROSIS, TAPER CORROSION, ELEVATED METAL IONS, PAIN, PSEUDOTUMOR, IN HER RIGHT HIP REQUIRING REVISION SURGERY SEVEN YEARS POST INITIAL HIP REPLACEMENT SURGERY. OPERATIVE REPORT FOUND METALLIC STAINED FLUID AND EVIDENCE OF METAL DEBRIS AND EVIDENCE OF BOTH ABDUCTOR MUSCLE NERCROSIS AND CAPSULAR TISSUE NECROSIS INVOLVING 30% OF ABDUCTOR MUSCLES ALONG WITH EVIDENCE OF EXTENSIVE CORROSION INSIDE THE FEMORAL HEAD AND THE TAPER. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125231 FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER PROSTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. N/A 61135465

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R