BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 17344467 · Received July 18, 2023

    Report

    Report Number
    0001822565-2023-01951
    Event Type
    Injury
    Date Received
    July 18, 2023
    Date of Event
    October 18, 2022
    Report Date
    July 18, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024137882
    PMA / PMN Number
    K182678
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2023 - 01950, 0001822565 - 2023 - 01952. D10: CAT#: 00877503602, LOT#: 3101756, BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14; CAT#: 00625006525, LOT#: 61288013, BONE SCR 6.5X25 SELF-TAP; CAT#: 00620005622, LOT#: 61237887, SHELL POROUS WITH CLUSTER HOLES 56 MM O.D.; CAT#: 00620105600, LOT#: 62683780, REPLACEMENT LOCKING RING FOR USE WITH 56 MM SHELL. A SEROMA IS A POCKET OF CLEAR SEROUS FLUID THAT SOMETIMES DEVELOPS IN THE BODY AFTER SURGERY. THIS FLUID IS COMPOSED OF BLOOD PLASMA THAT HAS SEEPED OUT OF RUPTURED SMALL BLOOD VESSELS AND INFLAMMATORY FLUID PRODUCED BY THE INJURED AND DYING CELLS. PROCEDURAL RELATED COMPLICATIONS ARE INFLUENCED BY THE ¿TYPE OF SURGERY, PATIENTS PRE-EXISTING COMORBID STATE, AND PERIOPERATIVE MANAGEMENT. HETEROTOPIC OSSIFICATION (HO) IS THE ABNORMAL AND RAPID GROWTH OF BONE THAT FORMS WITHIN SOFT TISSUE AS THE RESULT OF HEREDITY, TRAUMA, SURGICAL HISTORY, OR DISEASES OF A JOINT. THE RAPID AND IRREGULAR GROWTH OF BONE OFTEN CAUSES A SHARP OR JUTTED STRUCTURE TO FORM, WHICH CAN RESULT IN PAIN AND IRRITATION TO THE SURROUNDING TISSUES, OR THE PATIENT CAN REMAIN ASYMPTOMATIC. RADIATION OR NONSTEROIDAL ANTI-INFLAMMATORY MEDICATIONS ARE OFTEN PROVIDED TO PREVENT HO FORMATION. THE ONLY TREATMENT, IF NECESSARY, IS SURGICAL EXCISION OR SHAVING/SMOOTHING OUT THE EXCESS BONE. AS TIMEFRAMES OF ONSET DIFFER DUE TO INDIVIDUAL CONTRIBUTING FACTORS, A SPECIFIC TIMEFRAME OF EXPECTED OCCURRENCE CANNOT BE ESTABLISHED. DURING THE INVESTIGATION PROCESS A REVIEW OF THE STERILE CERTIFICATIONS WERE REVIEWED AND FOUND TO BE CONFORMING WITH NO APPLICABLE DEVIATIONS. DEVICES WERE VERIFIED TO HAVE GONE THROUGH ACCEPTABLE STERILIZATION PROCESS FOLLOWING ISO/AAMI/ASTM & EU PUBLISHED GUIDELINES. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE THE CONTROL OF ZIMMER BIOMET, SUCH AS EXTERNAL FACTORS, I.E. HOSPITAL/SURGICAL ENVIRONMENT, PROVIDER RELATED RISK FACTORS, AND/OR PATIENT COMORBIDITIES/RISK FACTORS. AS THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUES IDENTIFIED AFFECTING IMPLANT SAFETY OR EFFECTIVENESS, IMPLANTED PRODUCTS ARE NOT IDENTIFIED AS THE SOURCE OR CONTRIBUTING TO THE REPORTED INFECTION. 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 REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY REVISION. AFTER THE REVISION, THE PATIENT DID VERY WELL THEN PRESENTED WITH SUDDEN ONSET SWELLING ALONG THE DISTAL INCISION. AS THERE WERE NO CLINICAL INDICATIONS OF INFECTION, THIS WAS THOUGHT TO BE A SEROMA, AND THE PATIENT WAS SCHEDULED FOR AN INCISION AND DRAINAGE PROCEDURE. DURING THE PROCEDURE APPROXIMATELY 1-MONTH POST-REVISION, THE AREA OF THE SEROMA HAD A SLIGHT BROWN TINGE IN THE FLUID, BUT NO GROSS PURULENCE NOTED. THE SOFT TISSUES WERE THEN DEBRIDED WHICH REVEALED DEFECTS IN THE ILIOTIBIAL BAND WITH HETEROTOPIC OSSIFICATION AND GRANULATION TISSUE. AN EXTENSIVE IRRIGATION AND DEBRIDEMENT WAS PERFORMED WITH PLACEMENT OF ANTIBIOTIC BEADS. THE STEM AND SHELL WERE LEFT IN PLACE. ALL OTHER COMPONENTS WERE REVISED WITHOUT COMPLICATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142894 MODULAR NECK B 12/14 NECK TAPER USE WITH +0 HEADS ONLY PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 65376852 00889024137882

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R