BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER OPTION TYPE 1 TPR SLEVE -3

    MDR report key: 18474798 · Received January 9, 2024

    Report

    Report Number
    3002806535-2024-00014
    Event Type
    Injury
    Date Received
    January 9, 2024
    Date of Event
    November 14, 2023
    Report Date
    February 5, 2024
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271472
    PMA / PMN Number
    K200959
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PAIN IS A NORMAL ANTICIPATED FINDING DURING THE POSTOPERATIVE RECOVERY AS THE WOUND, MUSCLES AND TISSUE HEAL AND AS THE NEW JOINT IMPLANT IS BEING USED. PAIN SHOULD BE NONE TO MODERATE, ANYTHING GREATER THAN MODERATE WOULD BE CONSIDERED AN ABNORMAL FINDING. AS THE REPORT INDICATED THE PATIENT SOUGHT MEDICAL CARE BY GOING TO THE HOSPITAL, IT CAN BE IMPLIED THE PATIENT WAS EXPERIENCING ABNORMAL PAIN. AS COMPLAINT REPORTS PATIENT WENT TO HOSPITAL FOR CARE FOR PAIN, IT CAN BE IMPLIED THAT MEDICAL INTERVENTION WAS PROVIDED, THEREFORE MEDICAL COMPLAINT CATEGORY, MEDICAL: PAIN WOULD BE APPROPRIATE. TENDONITIS IS THE INFLAMMATION OR IRRITATION OF THE TENDONS AND IS TYPICALLY CAUSED BY REPETITIVE MOTION, OVERUSE AND PRESSURE TO THE BURSAE. SYMPTOMS THE PATIENT CAN EXPERIENCE, PAIN, TENDERNESS, SWELLING, STIFFNESS, DECREASE IN MOVEMENT, AND/OR REDNESS AT OR AROUND THE JOINT THAT IS INVOLVED. THIS CAN IMPACT THE PATIENTS¿ ABILITY TO USE THE JOINT TO THEIR FULL POTENTIAL. PATIENT CAN EXPERIENCE A DECREASE WITH OVERALL ADLS, ROM OF THE JOINT, DECREASE IN QUALITY OF LIFE, AS WELL AS INCREASING THE NEED FOR POSSIBLE OVER THE COUNTER (OTC) MEDICATIONS FOR SWELLING AND PAIN CONTROL. TREATMENT FOR TENDONITIS CAN CONSIST OF, OTC MEDICATIONS, SUCH AS TYLENOL AND ANTI-INFLAMMATORIES, PRESCRIBED PAIN MEDICATIONS, PHYSICAL THERAPY, REST, ICE, ELEVATING THE AFFECTED JOINT AND STEROID INJECTIONS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - MEDICAL DEVICES: CER BIOLOXD OPTION HD 36MM; ITEM# 650-1057; LOT# 965570 G7 PPS LTD ACET SHELL 50D; ITEM# 010000662; LOT# 3389888 G7 NEUTRAL E1 LINER 36MM D; ITEM# 010000856; LOT# 3364238 TPRLC 133 MP T1 PPS SO 8X101MM; ITEM# 51-108080; LOT# 3391462 MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535 - 2024 - 00013. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED A STUDY PATIENT, WITH A HISTORY OF HIP DYSPLASIA, HAD AN INITIAL RIGHT HIP ARTHROPLASTY. SUBSEQUENTLY, HAS HAD HIP PAIN SINCE SURGERY, HAD AN MRI THAT DISPLAYED MINIMAL GREATER TROCHANTER BURSITIS. LATER PAIN WAS NOTED AS INTERMITTENT, SEVERE WITH WALKING, AND AGGRAVATED WITH LIFTING LEG IN STRAIGHT LEG RAISE, LIFTING KNEE, LYING, AND TWISTING. REPORTS PAIN RELIEF WITH SITTING AND SINCE WAS DIAGNOSED WITH PSOAS TENDINITIS. WAS REFERRED TO A SPINE SPECIALIST FOR CHRONIC BACK PAIN AND CURRENTLY BEING TREATED CONSERVATIVELY WITH THE OPTION OF INJECTION IF THE PAIN WORSENS. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605156 CER OPTION TYPE 1 TPR SLEVE -3 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO BIOMET UK LTD. N/A 339980 00887868271472

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SEE H10 NARRATIVE.