BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG RT LG SIZE 4 PMA

    MDR report key: 10926776 · Received December 1, 2020

    Report

    Report Number
    3002806535-2020-00508
    Event Type
    Injury
    Date Received
    December 1, 2020
    Date of Event
    October 29, 2020
    Report Date
    March 1, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279786299
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRODUCTS HAVE BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION AND FORWARDED TO A RESEARCH ENGINEER FOR INVESTIGATION. THE EVENT REPORTS THE BEARING WAS REVISED DUE TO FRACTURE AFTER APPROXIMATELY 11 YEARS AND 6 MONTHS IN USE. THE FEMORAL AND TIBIAL COMPONENTS WERE LEFT IN VIVO. THE COMPONENT WAS RECEIVED SPLIT IN TWO FRAGMENTS, BOTH PRESENTING EXTENSIVE WEAR AND MATERIAL LOSS FROM THE SUPERIOR ARTICULATING SURFACE, THE MEDIAL SIDE AND BOTH THE ANTERIOR AND POSTERIOR ASPECT. THE THICKNESS OF THE CENTRAL REGION WAS FOUND TO HAVE REDUCED DURING SERVICE TO 3.20 MM BELOW ITS NOMINAL THICKNESS, INDICATING A WEAR RATE OF APPROXIMATELY 0.28 MM/YEAR. TWELVE IMAGES WITH A TOTAL OF TWENTY-FOUR RADIOGRAPHS WERE PROVIDED. IN ALL PROVIDED RADIOGRAPHS, THE POSITIONING AND SIZING OF THE FEMORAL COMPONENT APPEARS IN AGREEMENT WITH THE RECOMMENDATIONS OF THE APPLICABLE OXFORD SURGICAL TECHNIQUE. IN THE ANTEROPOSTERIOR RADIOGRAPHS, THE MEDIAL EDGE OF THE TIBIAL TRAY APPEARS TO BE OVERHANGING FROM THE MEDIAL EDGE OF THE TIBIAL PLATEAU; THE OXFORD SURGICAL TECHNIQUE RECOMMENDS THE MEDIAL EDGE OF THE TIBIAL TRAY TO BE FLUSH OR WITH LESS THAN 2 MM OVERHANG FROM THE MEDIAL EDGE OF THE TIBIAL PLATEAU. THE THINNING OF THE POLYETHYLENE BEARING CAN BE OBSERVED IN THE PROVIDED ANTEROPOSTERIOR RADIOGRAPHS, WHERE THE FEMORAL COMPONENT APPEARS TO GET CLOSER TO THE MARKER WIRE OF THE BEARING OVER THE YEARS. THE INFORMATION FOR USE DOCUMENT (5401000201 REV. 2) INCLUDED WITH THE POLYETHYLENE BEARING PROVIDED THE FOLLOWING INFORMATION: WARNINGS: 1) IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS. 5) MALALIGNMENT OR SOFT TISSUE IMBALANCE CAN PLACE INORDINATE FORCES ON THE COMPONENTS, WHICH MAY CAUSE EXCESSIVE WEAR TO THE PATELLAR OR TIBIAL BEARING ARTICULATING SURFACES. REVISION SURGERY MAY BE REQUIRED TO PREVENT COMPONENT FAILURE. PRECAUTIONS: 2) BIOMET JOINT REPLACEMENT PROSTHESES PROVIDE THE SURGEON WITH A MEANS OF REDUCING PAIN AND RESTORING FUNCTION FOR MANY PATIENTS. WHILE THESE DEVICES ARE GENERALLY SUCCESSFUL IN ATTAINING THESE GOALS THEY CANNOT BE EXPECTED TO WITHSTAND THE ACTIVITY LEVELS AND LOADS OF NORMAL HEALTHY BONE AND JOINT TISSUE. POSSIBLE ADVERSE EFFECTS: WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A COMPLAINT HISTORY REVIEW IDENTIFIED ONE SIMILAR COMPLAINTS FOR THE SAME ITEM NUMBER. A COMPLAINT HISTORY REVIEW IDENTIFIED NO SIMILAR COMPLAINTS FOR THE SAME LOT NUMBER. THIS DEVICE IS USED FOR TREATMENT. THE LIKELY CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET IS CONFORMING TO SPECIFICATION. IT IS NOT POSSIBLE TO CONFIRM THE EXACT ROOT CAUSE OF THE EXCESSIVE WEAR AND FRACTURE OF THE OXFORD BEARING IN THIS INSTANCE. HOWEVER, SOME DEGREE OF TISSUE LAXITY AND PROGRESSION OF OSTEOARTHRITIS IN THE PATELLOFEMORAL JOINT MAY HAVE CAUSED ABNORMAL LOADS TO BE TRANSFERRED TO THE POLYETHYLENE COMPONENT, THUS CONTRIBUTING TO ITS FAILURE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY. RISK ASSESSMENT: RELEVANT RISK MANAGEMENT FILE RELEVANT LINE: MULTIPLE LINES COVER A HARM OF NON-FUNCTIONING JOINT. THE SEVERITY SCORE ASSOCIATED WITH THIS FAILURE MODE IS 3 (NECESSITATES MINOR MEDICAL INTERVENTION) WITH AN OCCURRENCE SCORE OF 2 (BETWEEN 1 IN 10,000 AND 1 IN 100,000). SEVERITY ASSESSMENT THIS EVENT RESULTED IN REVISION SURGERY APPROXIMATELY 11 YEARS AND 6 MONTHS FOLLOWING IMPLANTATION. THIS GIVES A SEVERITY SCORE OF 3. THE SEVERITY SCORE IS IN LINE WITH THE RISK FILE. OCCURRENCE: NUMBER OF ITEMS SOLD - (B)(4). COMPLAINT HISTORY SEARCH CRITERIA - DATE: JAN 2017 TO FEB 2021 (CURRENT DATE) NUMBER OF COMPLAINTS IDENTIFIED - 2 OCCURRENCE RATIO - 2: 11129 = 1: 5565 THIS GIVES AN OCCURRENCE SCORE OF 3. AS THE HAZARD FOR THE IDENTIFIED COMPLAINTS HAS NOT BEEN DETERMINED, IT IS NOT REASONABLE TO ASSIGN BOTH EVENTS TO THE SAME LINE IN THE RISK FILE, THEREFORE, THE CALCULATED OCCURRENCE RATE AND OCCURRENCE SCORE CAN NOT BE USED FOR COMPARISON WITH THE RISK FILE, AND NO ISSUE WITH THE OCCURRENCE RATE/SCORE HAS BEEN IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY ON (B)(6)2009. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO BEARING FRACTURE WAS PERFORMED ON (B)(6)2020. IT WAS NOTED THAT THE POLY HAD WORN VERY THIN PRIOR TO FRACTURE.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. PATIENT INFORMATION NOT ALLOWED BY COUNTRY REGULATIONS REPORT SOURCE, FOREIGN: EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS AVAILABLE TO BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: OXFORD PH3 CEMENTLESS FEM SZ L, CATALOG #: 154927, LOT #: 1661438. MEDICAL PRODUCT: OXF UNI CMNTLS TIB SZ E RM, CATALOG #: 166579, LOT #: 1605057. SURGEON WHO PERFORMED THE INITIAL PROCEDURE IS (B)(6). 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 WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO BEARING FRACTURE WAS PERFORMED ON (B)(6) 2020. IT WAS NOTED THAT THE POLY HAD WORN VERY THIN PRIOR TO FRACTURE. A FULL EVALUATION/REPORT IS REQUESTED BY THE HOSPITAL: REQUEST FOR ANALYSIS REPORT. REQUEST FOR INFORMATION ON SIMILAR FAILURES GLOBALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1392729 OXF ANAT BRG RT LG SIZE 4 PMA UNICONDYLAR KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 1640334 05019279786299

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEEH10