BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG RT SM SIZE 5 PMA

    MDR report key: 13497870 · Received February 9, 2022

    Report

    Report Number
    3002806535-2022-00062
    Event Type
    Injury
    Date Received
    February 9, 2022
    Report Date
    March 7, 2022
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279786169
    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 DOCUMENT IS BEING SUBMITTED TO RELAY SUPPLEMENTAL INFORMATION. D10: MEDICAL PRODUCT: OXFORD PKS C/LESS FEMORAL COCR SZ SMALL PC/HA CATALOGUE NUMBER: 154925. LOT NUMBER: UNKNOWN. MEDICAL PRODUCT: OXFORD UNI C/LESS TIBIAL TRAY RM B CATALOGUE NUMBER: 166573 LOT NUMBER: UNKNOWN . MEDICAL PRODUCT: OXFORD PKS ANAT MEN BRG UHMWPE RT SML SZ 5 CATALOGUE NUMBER: 159570. LOT NUMBER: UNKNOWN. MEDICAL PRODUCT: BLADE KIT CATALOGUE NUMBER: 11-3585. LOT NUMBER: UNKNOWN. SUPPLEMENTAL INFORMATION ACQUIRED: EXPLANT DATE. ASSOCIATED PRODUCTS. THE INVESTIGATION IS CURRENTLY UNDERWAY. ONCE THE INVESTIGATION HAS CONCLUDED, A FOLLOW-UP MDR WILL BE TENDERED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SUMMARY: ADEQUATE PHOTOGRAPHS HAVE NOT BEEN PROVIDED AND PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, THE INVESTIGATION HAS BEEN LIMITED TO THE INFORMATION PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE CARRIED OUT AS THE LOT NUMBER IS UNKNOWN. REVIEW OF COMPLAINT HISTORY IDENTIFIED 6 ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM. THIS DEVICE IS USED FOR TREATMENT. THE REPORTED EVENT IS NOT RELATED TO A COMBINATION OF PRODUCTS; THEREFORE, A COMPATIBILITY REVIEW IS NOT APPLICABLE. IT HAS BEEN CONFIRMED THAT THE IMPLANT IS NOT WITHIN THE SCOPE OR SUBJECT OF ANY FIELD ACTIONS OR RECALLS WHICH COULD BE ATTRIBUTED TO REPORTED EVENT. THE LIKELY CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET IS CONFORMING TO SPECIFICATION. THE REPORTED EVENT HAS NOT BEEN CONFIRMED AS RELEVANT PHOTOGRAPHS HAVE NOT BEEN PROVIDED AND PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE INVESTIGATION IS COMPLETED BASED ON CURRENT AVAILABLE INFORMATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND FURTHER INVESTIGATED. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    (B)(4). INITIAL REPORT. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THE CLIENT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR AN INVESTIGATION. THE INVESTIGATION IS CURRENTLY UNDERWAY. ONCE THE INVESTIGATION HAS CONCLUDED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT: A PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY ON (B)(6), 2013. SUBSEQUENTLY, THE PATIENT HAD PAIN AND INSTABILITY WHICH REQUIRED A POLY EXCHANGE TO A THICKER BEARING WHICH WAS PERFORMED ON AN UNKNOWN DATE. PATIENT OUTCOME: REVISION. NO DELAY. 28 FEB 2022 ADDI SURGEON - DR (B)(6) INITIAL PROCEDURE PERFORMED - (B)(6) HOSPITAL NO LOT NUMBERS AVAILABLE ORIGINAL IMPLANTS ARE LISTED BELOW: 154925 OXFORD PKS C/LESS FEMORAL COCR SZ SMALL PC/HA 166573 OXFORD UNI C/LESS TIBIAL TRAY RM B 159570 OXFORD PKS ANAT MEN BRG UHMWPE RT SML SZ 5 11-3585 BLADE KIT THE ORIGINAL SURGEON HAPPENED IN 2013 AND NO RECORDS WERE AVAILABLE AT THE TIME OF REVISION. DATE OF REVISION WAS (B)(6) 2022 WERE THERE ANY PATIENT-SPECIFIC INDICATIONS THAT COULD HAVE LED TO THE REVISION? NO, THE SURGEON DID NOT BELIEVE SO. NO OTHER IMPLANTS WERE REMOVED OR REVISED, UNFORTUNATELY, NO LOT NUMBER WAS AVAILABLE. EXPLANTED IMPLANT NOT RETURNED DUE TO HOSPITAL POLICY.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT: A PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, THE PATIENT HAD PAIN AND INSTABILITY WHICH REQUIRED A POLY EXCHANGE TO A THICKER BEARING WHICH WAS PERFORMED ON AN UNKNOWN DATE. PATIENT OUTCOME: REVISION. NO DELAY.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT: THE PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, THE PATIENT HAD PAIN AND INSTABILITY WHICH REQUIRED A POLY EXCHANGE TO A THICKER BEARING WHICH WAS PERFORMED ON AN UNKNOWN DATE. PATIENT OUTCOME: REVISION. NO DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1087295 OXF ANAT BRG RT SM SIZE 5 PMA OXFORD HXLPE BEARINGS NRA BIOMET UK LTD. N/A UNKNOWN 05019279786169

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention| H