BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE

    MDR report key: 4899691 · Received July 8, 2015

    Report

    Report Number
    0001825034-2015-02897
    Event Type
    Injury
    Date Received
    July 8, 2015
    Report Date
    June 12, 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
    CA, 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 WAS NOT PROVIDED FOR THE PATIENTS MENTIONED IN THE JOURNAL ARTICLE. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN. EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - UNKNOWN. DATE EXPLANTED - UNKNOWN. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY MCPHERSON, E.J. ET AL. JISRF RECONSTRUCTIVE REVIEW, VOLUME 5, NUMBER 1, MARCH 2015. DOI: 10.15438/RR.5.1.102. MANUFACTURE DATE ¿ UNKNOWN. IT IS LIKELY THAT THESE COMPLICATIONS AND REVISIONS 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, "INCISION LENGTH IN SMALL INCISION TOTAL KNEE ARTHROPLASTY: HOW LONG OF AN INCISION IS NEEDED?" THIS PROSPECTIVE REVIEW STUDIED INCISION LENGTH WITH A SMALL INCISION TKA TECHNIQUE AND COMPARED MEASURED INCISION LENGTHS TO VARIOUS ANATOMIC AND CLINICAL PARAMETERS. THIS STUDY PROSPECTIVELY REVIEWED 357 CASES OF PRIMARY TOTAL KNEE ARTHROPLASTY USING A SMALL PARAMEDIAL INCISION AND UTILIZING SMALL INCISION INSTRUMENTATION. BY USING LINEAR REGRESSION ANALYSIS, IT WAS FOUND THAT INCISION LENGTH WAS GENERALLY RELATED TO THE WIDTH OF THE DISTAL CUT FEMUR AND THE WIDTH OF THE PROXIMAL CUT TIBIA. INCISION LENGTH WAS NOT RELATED TO HEIGHT, WEIGHT, BMI, OR FEMORAL IMPLANT WIDTH. CLINICALLY BASED UPON THIS DATA, A REASONABLE STARTING INCISION FOR SMALL INCISION TKA (AS MEASURED IN KNEE EXTENSION) IS A LENGTH THAT IS 1.6 TIMES THE MEASURED WIDTH OF THE DISTAL FEMUR. THE SURGEON SHOULD ALWAYS EXTEND THE INCISION IF HE/SHE ENCOUNTERS DIFFICULTY IN EXPOSURE AND/OR PLACEMENT OF INSTRUMENTATION. THE VANGUARD TOTAL KNEE SYSTEM¿ (BIOMET, INC., (B)(4)) WAS USED IN ALL CASES. ALL PATELLAE WERE RESURFACED WITH A 3 PEG POLYETHYLENE REDUCED THICKNESS IMPLANT (BIOMET, INC., (B)(4)), A SUBSET OF IMPLANTS THAT ARE 15% THINNER THAN THE STANDARD PATELLAR IMPLANT. ALL IMPLANTS WERE CEMENTED USING COBALT CEMENT (BIOMET, INC., (B)(4)) WITHOUT ANTIBIOTICS. THE NUMBER OF KNEES MEASURED IN THIS STUDY WAS 357, CONSISTING OF 291 PATIENTS. THERE WERE 214 FEMALE CASES AND 143 MALE CASES. THE AVERAGE AGE OF THE STUDY GROUP WAS 65.5 YEARS (33-91). IN THE FEMALE GROUP THE AVERAGE AGE WAS 65.8 YEARS (33-91) AND IN THE MALE GROUP THE AVERAGE AGE WAS 65.2 YEARS (33-85). THERE WERE 17 CASES WHICH REQUIRED MANIPULATION (4.8%). ALL MANIPULATIONS WERE PERFORMED BETWEEN 5 TO 7 WEEKS. THERE WERE 7 COMPLICATIONS AS A RESULT OF MILD HYPEREXTENSION THAT REQUIRED A MODULAR BEARING EXCHANGE IN ALL INSTANCES. WE ATTRIBUTE THE HYPEREXTENSION DEFORMITY TO CUTTING TOO MUCH POSTERIOR SLOPE WHICH ALLOWED THESE KNEES TO DEVELOP HYPEREXTENSION OVER A PERIOD OF 1 TO 3 YEARS. WE HAVE SINCE REDUCED THE EXTENT OF OUR POSTERIOR SLOPE CUT. THERE WERE 6 CASES OF INFECTION (1.7%) IN THIS SERIES. IN THIS STUDY, THE LOWER LIMITS OF INCISION LENGTH WERE TESTED. WE FOUND THAT AN INCISION LENGTH (MEASURED IN EXTENSION) THAT IS APPROXIMATELY 1.6 TIMES THE WIDTH OF THE DISTAL FEMUR IS A REASONABLE MEASUREMENT TO USE FOR A SMALL INCISION TKA TECHNIQUE. THIS RULE WOULD PROVIDE A UNIFORM STARTING POINT FOR THE SURGEON AND CREATE CONSISTENCY IN SURGICAL TECHNIQUE. IF THE SURGEON ENCOUNTERS DIFFICULTY WITH EXPOSURE (ESPECIALLY WITH A STIFF KNEE WITH A THICK SUBCUTANEOUS LAYER) THE INCISION SHOULD ALWAYS BE EXTENDED TO ADDRESS THE EXPOSURE NEEDS OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442363 UNKNOWN KNEE PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R