BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN AGC KNEE

    MDR report key: 5516246 · Received March 22, 2016

    Report

    Report Number
    0001825034-2016-00950
    Event Type
    Death
    Date Received
    March 22, 2016
    Report Date
    October 26, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    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 WERE NOT PROVIDED FOR THE PATIENT MENTIONED IN THE JOURNAL ARTICLE. SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. THE AVERAGE AGE OF THE PATIENTS AT THE TIME OF TOTAL KNEE REPLACEMENT WAS 70.4 YEARS. DATE OF EVENT - UNKNOWN THE ARTICLE WAS WRITTEN BY KEATING, E.M. ET AL. IN CLINICAL ORTHOPAEDICS AND RELATED RESEARCH (2002). DOI 10.1097/01.BLO.0000030485.77561.57. (B)(4). PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND TO CORRECT PREVIOUSLY REPORTED INFORMATION: THE FOLLOWING SECTIONS WERE CORRECTED: AGE AT TIME OF EVENT, PATIENT SEX, BRAND NAME, DEVICE EVALUATED BY MANUFACTURER. THE FOLLOWING SECTIONS WERE UPDATED: 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 SURGEON REFUSED TO RETURN. 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.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON A REVIEW OF THE JOURNAL ARTICLE, "LONG-TERM FOLLOW-UP OF NON-MODULAR TOTAL KNEE REPLACEMENTS." THE PURPOSE OF THE CURRENT STUDY WAS TO EVALUATE AND DETERMINE THE MECHANISM AND ETIOLOGY OF FAILURE OF COMPONENTS THAT FAILED IN LONG-TERM FOLLOW-UP OF ANATOMIC GRADUATED COMPONENT TOTAL KNEE REPLACEMENTS. THE AUTHORS PREVIOUSLY REPORTED THE SURVIVORSHIP OF 4583 ANATOMIC GRADUATED COMPONENT TOTAL KNEE ARTHROPLASTIES DONE DURING A 17-YEAR PERIOD. THE CURRENT STUDY WAS DONE TO EVALUATE THE ETIOLOGY AND CAUSE OF FAILURE OF THE COMPONENTS THAT FAILED. FOUR THOUSAND NINE HUNDRED THIRTEEN AGC PRIMARY TOTAL KNEE REPLACEMENTS WERE DONE IN 3328 PATIENTS BETWEEN SEPTEMBER 1983 AND DECEMBER 1996. IN 1983, THE CURRENT AUTHORS BEGAN USING A CEMENTED FLAT-ON- FLAT TOTAL KNEE REPLACEMENT WITH NON-MODULAR METAL-BACKED TIBIA COMPONENTS, AGC (BIOMET, (B)(4)), IN PATIENTS HAVING PRIMARY TOTAL KNEE REPLACEMENT. A METAL-BACKED PATELLA WAS USED IN 296 KNEES AND AN ALL-POLYETHYLENE COMPONENT WAS USED IN 4287 KNEES. ALTHOUGH THE SUCCESS AND SURVIVAL OF THESE PROSTHESES HAS BEEN REPORTED, THE CURRENT STUDY WAS DONE TO DETERMINE THE MECHANISM AND ETIOLOGY OF FAILURE OF THE COMPONENTS THAT FAILED. SIXTY PERCENT OF THE PATIENTS WERE WOMEN. THE PRIMARY DIAGNOSIS WAS OSTEOARTHRITIS (87% OF PATIENTS). SIXTY-TWO KNEES IN 62 PATIENTS WERE EXCLUDED BECAUSE OF INFECTION FOR A RATE OF 1.3%. THERE WERE 58 REVISIONS IN 57 PATIENTS AND 155 PATIENTS (210 KNEES) WERE LOST TO FOLLOW-UP (4.2%). THIS LEFT 4583 TOTAL KNEE REPLACEMENTS DONE ON 3054 PATIENTS. FAILURE WAS DEFINED AS LOOSENING, REVISION OF ANY COMPONENT, OR A RECOMMENDATION FOR REVISION OF ANY COMPONENT. PROSTHESES WERE CONSIDERED LOOSE IF THEY HAD A COMPLETE RADIOLUCENT LINE, MIGRATED, OR HAD A CHANGE IN ALIGNMENT. THE FOLLOWING COMPLICATIONS WERE REPORTED: THREE HUNDRED EIGHTY-EIGHT (388) PATIENT DEATHS DURING THE FOLLOW-UP PERIOD SIX (6) REVISIONS DUE TO FEMORAL LOOSENING ONE (1) REVISION DUE TO PERIPROSTHETIC FRACTURE CAUSED BY PATIENT FALL ONE (1) REVISION DUE TO INFECTION NINE (9) REVISIONS DUE TO TIBIAL LOOSENING TWO (2) CASES OF TIBIAL LOOSENING WITHOUT REVISION TEN (10) REVISIONS DUE TO TIBIAL LOOSENING CAUSED BY NON-HEALING OSTEONECROTIC LESION FOUR (4) REVISIONS DUE TO SUBLUXATION FOUR (4) REVISIONS DUE TO PAIN THERE WAS A 94.1% SURVIVAL AT 10 YEARS AND A 90.9% SURVIVAL AT 15 YEARS. IN SOME LONG-TERM SERIES, THE OUTCOME LEADING TO LOOSENING AND REVISION MOST LIKELY WAS RELATED TO A VARUS POSITION WITH A LIMB ALIGNMENT OF 4 VARUS OR LESS. BECAUSE OF THE LOW FAILURE RATE IN THE CURRENT SERIES, THIS WAS NOT STATISTICALLY SIGNIFICANT; HOWEVER, IT WOULD STAND TO REASON THAT THIS WOULD LEAD TO FAILURE, AS HAS BEEN REPORTED IN ANOTHER SERIES. THE MAJORITY OF FAILURES IN THE CURRENT SERIES WERE EITHER ATTRIBUTABLE TO TECHNIQUE OR TO AN OSTEONECROTIC LESION IN THE MEDIAL TIBIAL PLATEAU THAT PREVIOUSLY HAS NOT BEEN WELL-DESCRIBED.

    Description of Event or Problem · 1

    THREE HUNDRED EIGHTY-EIGHT (388) UNKNOWN PATIENTS WERE IDENTIFIED IN THE ARTICLE THAT UNDERWENT REPLACEMENT SURGERY DIED DURING THE FOLLOW UP PERIOD FOR UNKNOWN REASONS ON UNKNOWN DATES. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174143 UNKNOWN AGC KNEE PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| H| R