BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF UNI TIB TRAY SZ AA LM PMA

    MDR report key: 7280187 · Received February 19, 2018

    Report

    Report Number
    3002806535-2018-00371
    Event Type
    Injury
    Date Received
    February 19, 2018
    Date of Event
    January 23, 2018
    Report Date
    August 8, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    (B)(4). PRODUCTS HAVE BEEN RETURNED TO BIOMET ORTHOPEDICS LLC FOR EVALUATION AND FORWARDED TO A QUALITY ENGINEER FOR INVESTIGATION. SUMMARY OF INVESTIGATION: RETURNED PRODUCTS ARE PN: 159531, OXFORD TIBIAL TRAY, PN: 161468, OXFORD FEMORAL, AND PN: 159541, OXFORD TIBIAL BEARING. VISUAL INSPECTION SHOWS THAT ALL THREE ITEMS EXHIBIT SIGNS OF USE AS NICKS ,DINGS, AND SCRATCHES WERE FOUND (SEE DL672744). AS IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO TIBIAL OVERHANG, DIMENSIONAL ANALYSIS OF THE TIBIAL TRAY WAS COMPLETED AND IT WAS FOUND TO BE WITHIN SPECIFICATION AND CONFORMING WHERE MEASURED, INCLUDING DIMENSION F2 THE OVERALL M-L WIDTH OF THE TIBIAL TRAY AT IT'S WIDEST POINT (SEE DL672744). REVIEW OF THE DEVICE HISTORY RECORDS FOR 159531 LOT 469180 AND 161468 LOT 214340 IDENTIFIED NO DEVIATIONS OR ANOMALIES. REVIEW OF THE DEVICE HISTORY RECORDS FOR 159541 LOT 242010 IDENTIFIED AN UNRELATED DEVIATION/ANOMALY: ONE (1) UNIT SCRAPPED DUE FOREIGN DEBRIS IN THE POLY. REVIEW OF COMPLAINT HISTORY IDENTIFIED NO ADDITIONAL REPORTS FOR THE REPORTED PART AND LOT COMBINATION, 159531 LOT 469180. ADDITIONALLY, NO SIMILAR REPORTS WERE FOUND FOR ITEM 159531 BETWEEN JAN 1, 2017 AND JUL 17, 2018. KEYWORDS USED WERE "SIZE", "LARGE", "OVER", "HANG", AND "TISSUE". X-RAYS AND OTHER MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. AS RADIOGRAPHS WERE NOT PROVIDED, THE REPORTED EVENT OF TIBIAL TRAY OVERHANG COULD NOT BE VERIFIED. DIMENSIONAL ANALYSIS INDICATES THAT THE TIBIAL TRAY WAS LIKELY CONFORMING WHEN IT WAS RELEASED FROM ZIMMER BIOMET CONTROL. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE KNEE REVISION WAS DUE TO TIBIAL OVERHANG.

    Additional Manufacturer Narrative · 1

    (B)(4) MEDICAL PRODUCT - OXF TWIN-PEG CMNTD FEM SM PMA ITEM #161468, LOT # 214340, THERAPY DATE - (B)(6) 2018. MEDICAL PRODUCT - OXF ANAT BRG LT SM SIZE 4 PMA ITEM #159541, LOT # 242010, THERAPY DATE - (B)(6) 2018. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2018-00372, 3002806535-2018-00373. 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 LEFT KNEE PROCEDURE AND SUBSEQUENTLY THE PATIENT WAS REVISED DUE TO UNKNOWN REASON .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124274 OXF UNI TIB TRAY SZ AA LM PMA JWH BIOMET UK LTD. N/A 469180

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R