BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG LT SM SIZE 3 PMA

    MDR report key: 11840067 · Received May 18, 2021

    Report

    Report Number
    3002806535-2021-00202
    Event Type
    Injury
    Date Received
    May 18, 2021
    Date of Event
    October 6, 2020
    Report Date
    August 25, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279785865
    PMA / PMN Number
    P01004
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SUMMARY: AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. IN ADDITION, WE HAVE NOT BEEN PROVIDED WITH X-RAYS OR ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS NO ABNORMALITIES OR DEVIATIONS REPORTED. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND 3 COMPLAINTS REPORTED WITH THE ITEM 154718, 8 COMPLAINTS REPORTED WITH THE ITEM 161468 AND 4 COMPLAINTS REPORTED WITH THE ITEM 159540 (INCLUDING INITIATING COMPLAINT). WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00199-2. 3002806535-2021-00201-2. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE SUBMITTED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ADDITIONAL INFORMATION RECEIVED: PATIENT FIRST NAME : (B)(6), PATIENT LAST NAME : (B)(6), PATIENT ID : (B)(6), AGE : 68, PATIENT WEIGHT : 141 LBS (63.96 KG), PATIENT HEIGHT : 5 FT 3 IN (160.02 CM), BMI : 25, MEDICATION TO MANAGE THE PAIN : TRAMADOL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    MYMOBILITY CLINICAL STUDY: PROSPECTIVE MULTICENTER LONGITUDINAL COHORT STUDY INCLUDING AN INTERVENTIONAL (SOC) RCT SUB-STUDY REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY ON (B)(6)2020. SUBSEQUENTLY, ON (B)(6)2020 THE PATIENT ATTENDED THE PHYSICIAN'S OFFICE DUE TO BLEEDING FROM THE INCISION AREA. DIAGNOSIS WAS EFFUSION OF THE LEFT KNEE JOINT, WHICH WAS TREATED WITH ASPIRATION OF THE KNEE JOINT 2 DAYS LATER.

    Description of Event or Problem · 0

    MYMOBILITY CLINICAL STUDY: PROSPECTIVE MULTICENTER LONGITUDINAL COHORT STUDY INCLUDING AN INTERVENTIONAL (SOC) RCT SUB-STUDY REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY ON (B)(6) 2020. SUBSEQUENTLY, ON (B)(6) 2020 THE PATIENT ATTENDED THE PHYSICIAN'S OFFICE DUE TO BLEEDING FROM THE INCISION AREA. DIAGNOSIS WAS EFFUSION OF THE LEFT KNEE JOINT, WHICH WAS TREATED WITH ASPIRATION OF THE KNEE JOINT 2 DAYS LATER.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT CUSTOMER HAS CONFIRMED THAT THE PRODUCTS REMAIN IMPLANTED. MEDICAL PRODUCT: OXF UNI TIB TRAY SZA LM, CATALOG #: 154718, LOT #: 942230. MEDICAL PRODUCT: OXF TWIN-PEG CMNTD FEM SM PMA, CATALOG #: 161468, LOT #: 175520. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00199, 3002806535-2021-00201. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    MYMOBILITY CLINICAL STUDY: PROSPECTIVE MULTICENTER LONGITUDINAL COHORT STUDY INCLUDING AN INTERVENTIONAL (SOC) RCT SUB-STUDY REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY ON (B)(6) 2020. SUBSEQUENTLY, ON (B)(6) 2020 THE PATIENT ATTENDED THE PHYSICIAN'S OFFICE DUE TO BLEEDING FROM THE INCISION AREA. DIAGNOSIS WAS EFFUSION OF THE LEFT KNEE JOINT, WHICH WAS TREATED WITH ASPIRATION OF THE KNEE JOINT 2 DAYS LATER. ATTEMPTS HAVE BEEN MADE BUT NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736843 OXF ANAT BRG LT SM SIZE 3 PMA OXFORD PARTIAL KNEE SYSTEM NRA BIOMET UK LTD. N/A 335230 05019279785865

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other