BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GII OVAL RESURFACING PAT 32MM

    MDR report key: 5310742 · Received December 18, 2015

    Report

    Report Number
    1020279-2015-00865
    Event Type
    Injury
    Date Received
    December 18, 2015
    Date of Event
    July 1, 2014
    Report Date
    January 29, 2024
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    PMA / PMN Number
    K951987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO THE MANUFACTURER. EVALUATION - THE ASSOCIATED COMPLAINT DEVICES WERE NOT RETURNED. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY MANUFACTURING OR MATERIAL ABNORMALITIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. PER THE CONCERNS OF THE PATIENT AND RECALLS: NONE OF THE EXPLANT¿S LOT NUMBERS WERE INCLUDED IN ANY RECALLS. WITHOUT THE ACTUAL PRODUCT INVOLVED, OUR INVESTIGATION CANNOT PROCEED. IF THE DEVICE OR NEW INFORMATION IS RECEIVED IN THE FUTURE, THIS COMPLAINT CAN BE RE-OPENED. NO FURTHER ACTIONS ARE BEING TAKEN AT THIS TIME. WE CONSIDER THIS INVESTIGATION CLOSED. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION: CONCOMITANT DEVICE 510KS: K962557, K071071.

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED COMPLAINT DEVICES WERE NOT RETURNED. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY DEVIATIONS THAT COULD HAVE CAUSED THE REPORTED INCIDENT. A CLINICAL ANALYSIS INDICATED THAT THE REPORTED INDICATION OF TRAUMA, RADIOLOGICAL FINDINGS (LUCENCIES, PATELLAR SUBLUXATION AND BUTTON DISASSOCIATION) APPROXIMATELY 1 YEAR PRIOR TO THE 1ST REVISION ALONG WITH DELAYED SURGICAL INTERVENTION ARE ALL LIKELY CONTRIBUTING FACTORS TO THE REPORTED 1ST REVISION (C-0072101). THERE WERE NO MATERIAL/MANUFACTURING DEVIATIONS IDENTIFIED IN THE LAB ANALYSIS OF THE RETURNED COMPONENTS (C-179108) AND NO SUPPORTING DOCUMENTATION WAS PROVIDED REGARDING THE 2ND REVISION (C-179108); HOWEVER, THE NOTED GAP BETWEEN THE L WEDGE AND THE FEMORAL COMPONENT ALONG WITH THE PATCHY CEMENT/BONE ADHESION ON BOTH THE TIBIAL AND FEMORAL COMPONENTS COULD HAVE BEEN CONTRIBUTING FACTORS. THE PATIENT IMPACT BEYOND THE REVISION SURGERIES CANNOT BE DETERMINED. NO FURTHER MEDICAL ASSESSMENT CAN BE RENDERED AT THIS TIME. A REVIEW OF COMPLAINT HISTORY ON THE LISTED PARTS REVEALED NO PRIOR COMPLAINTS FOR THE LISTED BATCHES. WITHOUT THE ACTUAL PRODUCT INVOLVED, OUR INVESTIGATION CANNOT PROCEED. IF THE DEVICE OR NEW INFORMATION IS RECEIVED IN THE FUTURE, THIS COMPLAINT CAN BE RE-OPENED. NO FURTHER ACTIONS ARE BEING TAKEN AT THIS TIME. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S LEFT KNEE WAS REVISED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2015 DUE TO A FAILED PATELLA OF THE LEFT KNEE. PATELLA, INSERT, AND FEMORAL COMPONENT WERE EXCHANGED DURING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836940 GII OVAL RESURFACING PAT 32MM GENESIS II FEMORAL COMPONENT JWH SMITH & NEPHEW, INC. 10DM09142

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Hospitalization| R 71420132/10DM09142.| 71420166/10CT40953.| 71453112/09CM10442.| FEMORAL COMPONENT PART 71420136 LOT 10DM09142.| 71420132/10DM09142