BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    UNKNOWN OXFORD TIBIAL COMPONENT

    MDR report key: 22858199 · Received August 21, 2025

    Report

    Report Number
    3002806535-2025-00386
    Event Type
    Injury
    Date Received
    August 21, 2025
    Date of Event
    June 27, 2025
    Report Date
    April 17, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H1: THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE LITERATURE MDR REPORTING REVIEW AND REMEDIATION EFFORT BASED ON MDR REPORTING PROCESS AND FDA ADVERSE EVENT REPORTING REQUIREMENT. CAPA -07984 WAS OPENED ON FEB 27, 2026 TO ADDRESS CORRECTIONS. DEVICE PERFORMANCE AND/OR RISK PROFILE ARE NOT IMPACTED. IF ANY FURTHER INFORMATION 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). B3: EVENT DATE IS THE PUBLICATION DATE OF THE ARTICLE. D4: THE PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER IS NOT APPLICABLE AS THE DEVICE'S PRODUCT NUMBER IS UNKNOWN. D10: UNKNOWN OXFORD BEARING; ITEM NUMBER: UNKNOWN; LOT NUMBER: UNKNOWN. UNKNOWN OXFORD FEMORAL COMPONENT; ITEM NUMBER: UNKNOWN; LOT NUMBER: UNKNOWN. MIDTERM FUNCTIONAL OUTCOMES AND SURVIVORSHIP OF OXFORD CEMENTED MEDIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY: A COMPREHENSIVE ANALYSIS OF THE INDIAN SCENARIO RAJANI AM, MITTAL AR, SHAH UA, KULKARNI VU, DUBEY R. ET AL.2025 JOURNAL OF CLINICAL ORTHOPAEDICS & TRAUMA, VOLUME 68, 103115 HTTPS://DOI.ORG/10.1016/J.JCOT.2025.103115. 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 MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND CORRECTED DATA. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G2, G3, G6, H2, H6, H10, H11. CORRECTED DATA: H6 COMPONENT CODES. THE PRODUCT HAS NOT BEEN EVALUATED, AS IT HAS BEEN DETERMINED THAT THE EVENT IS NOT RELATED TO THE DEVICE. THE REPORTED EVENT IS NOT RELATED TO THE DEVICE; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS AND COMPATIBILITY IS NOT APPLICABLE. THE ROOT CAUSE OF THE REPORTED EVENT IS NOT DEVICE RELATED. IT IS EXPECTED THAT A WOUND HEALS IN STAGES AND SHOULD BE OF NORMAL APPEARANCE RELATED TO THE TIMEFRAME SINCE THE INCISION WAS MADE. A SURGICAL WOUND SHOULD BE WELL APPROXIMATED WITHOUT REDNESS, WARMTH, SWELLING AND/OR PURULENT DRAINAGE FOR THE DURATION OF ITS HEALING. THE EXPRESSION WOUND CONCERNS OR NON-HEALING WOUND WOULD IMPLY THAT THE APPEARANCE OF THE WOUND DEVIATES FROM WHAT A SURGICAL WOUND SHOULD APPEAR. IT MAY BE RED, HAVE DRAINAGE, ADDITIONAL PAIN, WARMTH, AND SWELLING AS WELL AS HEALING TIME MAY BE DELAYED. THIS DEVIATION SIGNIFIES AN ALTERATION IN THE WOUND HEALING PROCESS, WHICH CAN BE COMPLICATED BY PATIENT COMORBIDITIES SUCH AS DIABETES, OBESITY, SMOKING, AND OTHER CONDITIONS THAT ARE KNOWN TO SLOW A PERSON¿S ABILITY TO HEAL. WOUND COMPLICATIONS CAN BE TREATED CONSERVATIVELY OR MORE INVASIVELY WITH AN IRRIGATION AND DEBRIDEMENT (I&D), WHICH PROMOTES HEALING AT THE SITE AND PREVENTS FURTHER COMPLICATIONS. IF DEEPER EXPLORATION OF THE WOUND IS WARRANTED AND THE JOINT SPACE IS ENTERED, A POLY EXCHANGE IS TYPICALLY PERFORMED IN CONJUNCTION WITH THE I&D TO CLEAR OUT ANY DEBRIS, HEMATOMA FORMATION, OR TO PREVENT DEEP JOINT INFECTION. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT 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.

    Description of Event or Problem · 0

    A JOURNAL ARTICLE WAS RETRIEVED FROM JOURNAL OF CLINICAL ORTHOPAEDICS AND TRAUMA (2025) THAT REPORTED A STUDY FROM INDIA. THE PURPOSE OF THE PROSPECTIVE STUDY WAS TO ASSESS THE MIDTERM FUNCTIONAL AND CLINICAL OUTCOMES, LONG-TERM SURVIVAL, AND COMPLICATIONS OF CEMENTED OXFORD UNICOMPARTMENTAL KNEE ARTHROPLASTY (UKA) IN INDIAN PATIENTS WITH ISOLATED AMOA AND TO ANALYZE THE FACTORS INFLUENCING ITS ACCEPTANCE AND SUCCESS. THE STUDY REVIEWED 180 PATIENTS, 191 KNEES. ALL PATIENTS UNDERWENT PRIMARY, OXFORD, CEMENTED, MOBILE-BEARING MEDIAL UKA, OPERATED UPON BY A SINGLE, SENIOR ARTHROPLASTY SURGEON, WHO HAD BEEN TRAINED AND CERTIFIED IN OXFORD UKA. SURGERY WAS DONE IN HANGING LEG POSITION UNDER SPINAL ANESTHESIA (BOTH UNILATERAL AND BILATERAL), AND TOURNIQUET CONTROL. THE INDICATION FOR SURGERY WAS KNEES DIAGNOSED CLINICALLY AND RADIOLOGICALLY WITH ISOLATED AMOA. THE STUDY POPULATION HAD A MEAN AGE OF 62.19 YEARS AT TIME OF SURGERY (RANGE: 44 TO 78); 66 MALES AND 114 FEMALES. FOLLOW-UP WAS CONDUCTED AT 2 WEEKS, 4 WEEKS, 6 WEEKS, 3 MONTHS, 6 MONTHS, 1 YEAR, 3 YEARS, AND 5 YEARS POST-SURGERY. NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT. THE STUDY REPORTED THREE KNEES HAD DELAYED WOUND HEALING (NOT REQUIRING SECONDARY CLOSURE).

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601730 UNKNOWN OXFORD TIBIAL COMPONENT KNEE PROTHESIS NRA BIOMET UK LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SEE H11 NARRATIVE.