BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCED PATELLA 35MM 3 PEG IMPLANT

    MDR report key: 18481148 · Received January 9, 2024

    Report

    Report Number
    1038671-2024-00059
    Event Type
    Injury
    Date Received
    January 9, 2024
    Date of Event
    August 29, 2018
    Report Date
    December 2, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862314291
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 02-020-11-0240 - TRULIANT PS CEM FEM PS CEM LEFT SZ 4: (B)(6). 02-022-45-4040 - TRULIANT TIB FIT TRAY CEM SZ 4F / 4T: (B)(6). 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT: (B)(6). 201-78-25 - SMALL HEADED SHARP PIN, 1 1/8" 4 PACK: (B)(6). 201-78-82 - COLLAR FIXATION PIN 2PK 40MM, QUICK RELEASE: (B)(6). 201-78-89 - 3" DRILL BIT, MOD. HEX 2 PACK: (B)(6). 201-78-89 - 3" DRILL BIT, MOD. HEX 2 PACK: (B)(6). 201-78-89 - 3" DRILL BIT, MOD. HEX 2 PACK: (B)(6).

    Description of Event or Problem · 0

    STUDY: (B)(6) CLINICAL STUDY. SUBJECT: (B)(6). AS REPORTED BY THE (B)(6) CLINICAL STUDY, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2018 AND PRESENTED ON (B)(6) 2018 WITH DISLOCATION - PROGRESSIVE LATERAL PATELLAR SUBLUXATION REPORTED ABOUT 3 MONTHS AGO POST-OP AND CONTINUED DESPITE PHYSICAL THERAPY AND BRACING. OPEN LATERAL RETINACULAR RELEASE WAS PERFORMED ON (B)(6) 2018 FOR PATELLAR SUBLUXATION LEFT TOTAL KNEE. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS UNKNOWN TO BE RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. MCL BRACE, PT AND OPEN LATERAL RETINACULAR RELEASE SURGERY (B)(6) 2018. THE OUTCOME OF THIS EVENT IS RESOLVED ON (B)(6) 2018. HEIGHT: 69 IN. DIAGNOSIS: OSTEOARTHRITIS. COMORBIDITIES: HYPERTENSION, INSULIN DEPENDENT DIABETES MELLITUS, CELIAC DISEASE, SLEEP APNEA, CHRONIC BACK PAIN, GERD, PERIPHERAL NEUROPATHY, SSS/PACEMAKER, BPH. 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT: (B)(6). 510K: K160484. CONCOMITANTS: 02-022-35-4015 - TRULIANT TIB IMP PS INSERT SZ 4 15MM: (B)(6). SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K152170. 02-020-11-0240 - TRULIANT PS CEM FEM PS CEM LEFT SZ 4: (B)(6). 02-022-45-4040 - TRULIANT TIB FIT TRAY CEM SZ 4F / 4T: (B)(6). 201-78-25 - SMALL HEADED SHARP PIN, 1 1/8" 4 PACK: (B)(6). 201-78-82 - COLLAR FIXATION PIN 2PK 40MM, QUICK RELEASE: (B)(6). 201-78-89 - 3" DRILL BIT, MOD. HEX 2 PACK: (B)(6). 201-78-89 - 3" DRILL BIT, MOD. HEX 2 PACK: (B)(6). 201-78-89 - 3" DRILL BIT, MOD. HEX 2 PACK: (B)(6). NO DEVICE RETURN ANTICIPATED DUE TO BEING A CLINICAL TRIAL STUDY. EBI INITIAL SURGERY ATTACHED. HISTORICAL RECORDS, SMARTSOLVE, AND INBOX SEARCHED FOR SERIAL NUMBERS AND/OR CLINICAL TRIAL SUBJECT WITH NO RESULTS. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682882 ADVANCED PATELLA 35MM 3 PEG IMPLANT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862314291

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female SEE H10