BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG RT MD SIZE 7 PMA

    MDR report key: 12850735 · Received November 22, 2021

    Report

    Report Number
    3002806535-2021-00505
    Event Type
    Injury
    Date Received
    November 22, 2021
    Date of Event
    November 17, 2021
    Report Date
    January 20, 2022
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ADDITIONAL INFORMATION RECEIVED: BRAND NAME: OXF ANAT BRG RT MD SIZE 7 PMA. COMMON DEVICE NAME: OXFORD HXLPE BEARINGS. DEVICE PRODUCT CODE: NRA. ITEM NUMBER: 159579. LOT NUMBER: 6781106. ITEM EXPIRATION DATE: APR 27, 2025. UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4). PMA/510(K) NUMBER: P010014. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SUMMARY: PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. THE ITEM AND LOT NUMBER HAVE NOT BEEN PROVIDED. X-RAYS OR MEDICAL NOTES HAVE NOT BEEN PROVIDED. THE INVESTIGATION HAS BEEN LIMITED TO THE INFORMATION PROVIDED. A HISTORICAL SEARCH COULD NOT BE PERFORMED AS THE ITEM AND LOT NUMBER HAVE NOT BEEN PROVIDED. THIS DEVICE IS USED FOR TREATMENT. NOT ENOUGH INFORMATION HAS BEEN PROVIDED TO DETERMINE IF ALL IMPLANTS ARE COMPATIBLE. A DHR REVIEW OR A REVIEW OF RECALLS COULD NOT BE PERFORMED AS THE ITEM AND LOT NUMBER HAVE NOT BEEN PROVIDED. THE LIKELY CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET COULD NOT BE DETERMINED AS THE ITEM AND LOT NUMBER HAS NOT BEEN PROVIDED. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS THE ROOT CAUSE OF THE REPORTED EVENT HAS NOT BEEN DETERMINED. 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. H3 OTHER TEXT: DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    (B)(4). INITIAL REPORT. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6) . CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY ON (B)(6) 2007. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO DISLOCATION WAS PERFORMED ON (B)(6) 2021.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY ON (B)(6) 2007. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO DISLOCATION WAS PERFORMED ON (B)(6) 2021.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY ON (B)(6) 2007. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO DISLOCATION WAS PERFORMED ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1747888 OXF ANAT BRG RT MD SIZE 7 PMA OXFORD HXLPE BEARINGS NRA BIOMET UK LTD. N/A 6781106
    1747892 OXF ANAT BRG RT MD SIZE 7 PMA OXFORD HXLPE BEARINGS NRA BIOMET UK LTD. N/A 6781106

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H