BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VANGUARD PS KNEE

    MDR report key: 4493429 · Received February 9, 2015

    Report

    Report Number
    0001825034-2015-00493
    Event Type
    Injury
    Date Received
    February 9, 2015
    Report Date
    February 17, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THERE WERE NO ADVERSE EFFECTS INVOLVING BIOMET PRODUCTS. THE INITIAL REPORT SHOULD BE VOIDED.

    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. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY YOUNG-JOON CHOI ET AL; KNEE SURG RELAT RES 2014;26(4):222-229 HTTP://DX.DOI.ORG/10.5792/KSRR.2014.26.4.222 PISSN 2234-0726 ¿ EISSN 2234-2451 (B)(6). IT IS LIKELY THAT THESE COMPLICATIONS HAVE ALREADY BEEN REPORTED; HOWEVER, IT CANNOT BE DETERMINED BASED ON THE LIMITED INFORMATION MADE AVAILABLE IN THE ARTICLE. SHOULD ADDITIONAL INFORMATION RELATING TO THE EVENTS BE RECEIVED, THE UPDATED INFORMATION WILL BE FORWARDED TO THE FDA.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE ENTITLED, "PERIOPERATIVE RISK ASSESSMENT IN PATIENTS AGED (B)(6): COMPARISON BETWEEN BILATERAL AND UNILATERAL TOTAL KNEE ARTHROPLASTY" WHICH AIMED TO EVALUATE THE RISK OF SEQUENTIAL BILATERAL TOTAL KNEE ARTHROPLASTY (TKA) UNDER ANESTHESIA IN PATIENTS (B)(6). THE STUDY WAS CONDUCTED OVER A PERIOD OF TEN YEARS (2002 AND 2012) AND INVOLVED A TOTAL OF THREE HUNDRED EIGHTEEN (318) PATIENTS. ALL PATIENTS WERE UNDER THE DIAGNOSIS OF PRIMARY KNEE OSTEOARTHRITIS. OF THESE (318) PATIENTS, ONE-HUNDRED FIFTY NINE (159) PATIENTS UNDERWENT SIMULTANEOUS BILATERAL TKA (BILATERAL GROUP) AND ONE-HUNDRED FIFTY NINE (159) PATIENTS UNDERWENT UNILATERAL TKA (UNILATERAL GROUP). FOR THE BILATERAL GROUP, THE JOURNAL ARTICLE REPORTS THE FOLLOWING ADVERSE EVENTS OCCURRED: SIX (6) POSTOPERATIVE MAJOR COMPLICATIONS OCCURRED AND ADDITIONAL TKA WAS NECESSITATED DUE TO THE DEVELOPMENT OF OSTEOARTHRITIS IN THE CONTRALATERAL KNEE DURING FOLLOW-UP, ALL OF WHICH WERE CARRIED OUT AT LEAST 2 YEARS AFTER THE INITIAL TKA. FOR THE UNILATERAL GROUP, FOUR (4) POSTOPERATIVE COMPLICATIONS OCCURRED AND ALTHOUGH THE COMPLICATION RATE OF THE BILATERAL GROUP WAS SLIGHTLY HIGHER THAN THAT OF THE UNILATERAL GROUP, THE DIFFERENCE WAS NOT STATISTICALLY MEANINGFUL (P=0.204) AND THE LENGTH OF HOSPITAL STAY WAS 21.9 DAYS FOR THE BILATERAL GROUP AND 24.9 DAYS FOR THE UNILATERAL GROUP. ONE OF THE PROSTHESIS OF CHOICE WAS THE VANGUARD POSTERIOR STABILIZED TYPE (BIOMET, (B)(4), USA). IN CONCLUSION, THERE WAS NO SIGNIFICANT DIFFERENCE IN POSTOPERATIVE COMPLICATIONS BETWEEN GROUPS. THE RESULT SHOWS THAT BILATERAL TKA CAN BE RELATIVELY SAFE COMPARED WITH UNILATERAL TKA IN PATIENTS (B)(6). HOWEVER, CAREFUL SELECTION OF LOW-RISK PATIENTS IS ADVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93267 UNKNOWN VANGUARD PS KNEE PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A UNKNOWN LOT

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R