BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN KNEE

    MDR report key: 4799884 · Received May 27, 2015

    Report

    Report Number
    0001825034-2015-02270
    Event Type
    Death
    Date Received
    May 27, 2015
    Report Date
    October 25, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    NRA
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSIONS AS TO THE CAUSE OF THE EVENTS. EVENT DETAILS AND PRODUCT IDENTIFICATION WAS NOT PROVIDED FOR THE PATIENTS MENTIONED IN THE JOURNAL ARTICLE.(B)(4)

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION: THE FOLLOWING SECTIONS WERE UPDATED: OUTCOMES ATTRIBUTED TO ADVERSE EVENT. ADDED ADDITIONAL INFORMATION. CATALOG AND LOT NUMBER. PATIENT AND DEVICE CODES. TYPE OF REPORTABLE EVENT. METHOD, RESULTS, AND CONCLUSION CODES. MANUFACTURER NARRATIVE. THE PRODUCT WAS NOT RETURNED FOR EVALUATION DUE TO UNKNOWN LOCATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER / LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DEVICE HISTORY RECORD (DHR) AND COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT/ITEM NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "COMPARISON OF OUTCOMES AFTER UKA IN PATIENTS WITH AND WITHOUT CHONDROCALCINOSIS: A MATCHED COHORT STUDY" WHICH AIMED TO REPORT THE OUTCOME OF A CONSECUTIVE SERIES OF PATIENTS WITH CHONDROCALCINOSIS AND MEDIAL COMPARTMENT OSTEOARTHRITIS TREATED WITH UKA MATCHED TO CONTROLS, USING THE OXFORD. THE STUDY CONSISTED OF 1013 CEMENTED PHASE 3 MEDIAL OXFORD UKA'S IMPLANTED BETWEEN 1998 AND 2008. 123 HAD EITHER RADIOLOGICAL (R-CCK) OR HISTOLOGICAL (H-CCK) EVIDENCE OF CHONDROCALCINOSIS AND 31 KNEES HAD BOTH HISTOLOGICAL AND RADIOLOGICAL CHONDROCALCINOSIS. EACH PATIENT WITH CHONDROCALCINOSIS WAS MATCHED TO 2 CONTROLS USING AN ALGORITHM. THE MEAN FOLLOW-UP WAS 10 YEARS. NINE OUT OF 123 KNEES WITH CHONDROCALCINOSIS UNDERWENT REVISION. SIX OUT OF 67 KNEES WERE IN THE H-CCK GROUP, 3 OUT OF 87 KNEES WERE IN THE R-CCK GROUP, AND 2 OUT OF 31 KNEES HAD BOTH HISTOLOGICAL AND RADIOGRAPHICAL EVIDENCE OF CHONDROCALCINOSIS. FOUR OUT OF 246 KNEES IN THE CONTROL GROUP UNDERWENT A REVISION. OF THE SIX KNEES IN THE HISTOLOGICAL CHONDROCALCINOSIS GROUP THAT UNDERWENT REVISION, ONE KNEE WAS REVISED FOR LATERAL COMPARTMENT OA. THE OTHER FIVE KNEES WITH CHONDROCALCINOSIS WERE REVISED DUE TO ASEPTIC LOOSENING IN ONE KNEE, BEARING DISLOCATION IN TWO KNEES, PERSISTENT PAIN IN ONE KNEE, AND LATERAL AVN IN ONE KNEE. IN THE 87 KNEES WITH RADIOLOGICAL CHONDROCALCINOSIS, THREE KNEES UNDERWENT REVISION FOR PERSISTENT PAIN, BEARING DISLOCATION, AND AVASCULAR NECROSIS OF LATERAL FEMORAL CONDYLE LEADING TO SECONDARY OA. IN CONCLUSION, THE PRESENCE OF R-CCK DOES NOT INFLUENCE FUNCTIONAL OUTCOME OR SURVIVAL FOLLOWING UKA. PRE-OPERATIVE RADIOLOGICAL EVIDENCE OF CCK SHOULD NOT BE CONSIDERED TO BE A CONTRAINDICATION TO UKA. H-CCK IS ASSOCIATED WITH SIGNIFICANTLY IMPROVED CLINICAL OUTCOMES BUT ALSO A HIGHER REVISION RATE COMPARED WITH CONTROLS.

    Description of Event or Problem · 1

    A REVIEW OF THE ARTICLE IDENTIFIED AN UNKNOWN NUMBER OF PATIENT DEATHS. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342355 UNKNOWN KNEE PROSTHESIS, KNEE NRA ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R