BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF UNI TIB TRAY SZ B LM PMA

    MDR report key: 10294568 · Received July 20, 2020

    Report

    Report Number
    3002806535-2020-00329
    Event Type
    Injury
    Date Received
    July 20, 2020
    Date of Event
    May 21, 2018
    Report Date
    July 30, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279388868
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00330-1, 3002806535-2020-00331-1. 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 4 SIMILAR COMPLAINTS REPORTED WITH THE ITEM: 154720, 16 SIMILAR COMPLAINTS REPORTED WITH THE ITEM: 161469 AND NO SIMILAR COMPLAINTS REPORTED WITH THE ITEM: 159550. NO TRENDS WERE IDENTIFIED FOR THE ITEMS: 154720 AND 159550. FOR ITEM: 161469, 4 COMPLAINTS WERE REPORTED WITH 2 SIMILAR HOSPITAL. IN MOST CASES, CAUSE COULD NOT BE DETERMINED. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. RISK ASSESSMENT: THE EVENT REPORTS REVISION DUE TO PAIN AND IMPLANT FAILURE. RISK MANAGEMENT REPORT DOCUMENTS THE ESTIMATED RESIDUAL RISK ASSOCIATED WITH THE DEVICE WITHIN THE REPORTED EVENT. THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED WITH THE INFORMATION CURRENTLY AVAILABLE, THEREFORE THE SPECIFIC FAILURE CAUSE WITHIN THE RISK TABLES COULD NOT BE SELECTED FOR COMPARISON. PAIN IS DOCUMENTED AS A POTENTIAL HARM AS AN OUTCOME OF A NUMBER OF HAZARDS ASSESSED BY THE RMF. PAIN IS CONSIDERED A SEVERITY OF 3: MODERATE, WHICH AS PER THE SEVERITY TABLE LISTED WITHIN THE RMR IS DEFINED AS PRESCRIBED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR BODY STRUCTURE. CONTRIBUTED TO MINOR, TEMPORARY, OR MEDICALLY REVERSIBLE INJURY. THE REPORTED EVENT ALSO STATES IMPLANT FAILURE. AS IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF IMPLANT FAILURE IN THIS INSTANCE WITHOUT PROVISION OF FURTHER INFORMATION, A RISK TABLE LINE CANNOT BE ASSIGNED. THE OUTCOME OF THIS COMPLAINT IS CONSIDERED TO BE WITHIN THE SEVERITY OF THE RMR. NO CORRECTIVE OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THIS TIME. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY. H3 OTHER TEXT : PRODUCT HAS NOT BEEN RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY THE PATIENT STATES TO HAVE BEEN REVISED DUE TO PAIN AND IMPLANT FAILURE. PATIENT STATED THE IMPLANT WENT BAD THREE TO FOUR MONTHS AFTER INITIAL SURGERY. IT HAD SHIFTED, DETERIORATED AND THE BOTTOM BONE WAS COMING OUT OF THE LET. PIECES OF THE DEVICE HAD SHREDDED.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. MEDICAL PRODUCT: OXF TWIN-PEG CMNTD FEM MD PMA EM MED, CATALOG #: 161469, LOT #: 279290. MEDICAL PRODUCT: OXF ANAT BRG LT MD SIZE 6 PMA MED SZ 6, CATALOG #: 159550, LOT #: 2981359. MEDICAL PRODUCT: OXFORD RES AESCULAP 3TI 3PK, CATALOG #: 506296, LOT #: 95Y156. . MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00330, 3002806535-2020-00331. 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 THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY THE PATIENT STATES TO HAVE BEEN REVISED DUE TO PAIN AND IMPLANT FAILURE. PATIENT STATED THE IMPLANT WENT BAD THREE TO FOUR MONTHS AFTER INITIAL SURGERY. IT HAD SHIFTED, DETERIORATED AND THE BOTTOM BONE WAS COMING OUT OF THE LET. PIECES OF THE DEVICE HAD SHREDDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758261 OXF UNI TIB TRAY SZ B LM PMA UNICONDYLAR KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 469230 05019279388868

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R