BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS FEMORAL STEM

    MDR report key: 5459943 · Received February 25, 2016

    Report

    Report Number
    1822565-2016-00382
    Event Type
    Injury
    Date Received
    February 25, 2016
    Report Date
    January 11, 2017
    Manufacturer
    ZIMMER INC
    Product Code
    LPH
    PMA / PMN Number
    PSEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OTHER DEVICES USED: CATALOG #00875101640, TRILOGY LONGEVITY POLY LINER, LOT #62998324- IMPLANTED (B)(6) 2015; CATALOG #00875706401, CONTINUUM SHELL WITH CLUSTER HOLES, LOT #61442591; THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH (B)(4). PART: 00784301708 LOT: 60568595 510(K) K953337, PART: 00875101640 LOT: 62998324 510(K) K151448, PART: 00875706401 LOT: 61442591 510(K) K151448. THERE WAS NO PRODUCT RETURNED BECAUSE IT REMAINS IMPLANTED; THEREFORE, NO PHYSICAL EVALUATION COULD BE CONDUCTED. DHR REVIEW SHOWS NO ANOMALIES OR DEVIATIONS THAT WOULD HAVE AFFECTED THE SURGICAL OUTCOME OR CONTRIBUTED TO THE REPORTED EVENT. THESE DEVICES ARE USED FOR TREATMENT. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ONE ADDITIONAL COMPLAINT FOR THE PART-LOT COMBINATION OF 00784301708-60568595; HOWEVER, THIS ADDITIONAL COMPLAINT WAS WHERE THIS CURRENT INVESTIGATION WAS DERIVED FROM. REVIEW OF THE COMPLAINT HISTORY FOR THE REMAINING PART-LOT COMBINATIONS IDENTIFIED NO ADDITIONAL COMPLAINTS. A PATIENT HISTORY REVIEW INDICATES THAT THIS IS THE THIRD REVISION OF THA AND THAT THE FIRST REVISION WAS DUE TO INFECTION AS WELL. REVIEW OF THE OPERATIVE NOTES INDICATE THAT THE PATIENT¿S ORIGINAL SURGERY WAS COMPLICATED BY A (B)(6) INFECTION. THE ORIGINAL THA USED COMPETITOR¿S PRODUCTS AND THE REVISION SURGERY PRODUCTS ARE UNKNOWN. THE OPERATIVE NOTES FOR (B)(6) 2015 INDICATE THAT ¿THERE WAS NO OVERT EVIDENCE OF INFECTION¿. ALSO, THE PATIENT SUSTAINED A FALL AFTER THE LATEST REVISION, WHERE ZIMMER IMPLANTS WERE USED, PRIOR TO DEVELOPING PAIN AND REDNESS. WITH THE INFORMATION PROVIDED, A SPECIFIC CAUSE FOR THE REPORTED CONDITION COULD NOT BE DETERMINED WITH CERTAINTY.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT IS EXPERIENCING CELLULITIS FOLLOWING THEIR MOST RECENT REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118335 VERSYS FEMORAL STEM LPH LPH ZIMMER INC 60568595

    Patients

    Seq Age Sex Outcome Treatment
    1 Other