BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DONJOY I-FLOW "PAINBUSTER PAIN PUMP 100ML

    MDR report key: 3972984 · Received July 29, 2014

    Report

    Report Number
    MW5037531
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    October 15, 2004
    Report Date
    June 30, 2016
    Manufacturer
    DJO LLC
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) FEMALE HAD SURGERY ON (B)(6) 2004 TO REPAIR A PARTIAL TORN ANTERIOR CRUCIATE LIGAMENT. UPON EXAMINATION, THE MEDIAL AND LATERAL COMPARTMENTS OF MY KNEE WERE NORMAL INCLUDING ARTICULAR CARTILAGE AND BOTH MENISCI. AN I-FLOW DONJOY PAINBUSTER PAIN PUMP WAS IMPLANTED INTO MY KNEE JOINT AN A DONJOY ICEMAN WAS APPLIED. THE PAIN PUMP WAS REMOVED ON (B)(6) 2004. I DEVELOPED A SEVERE INJURY FROM THE ICEMAN CRYOTHERAPY UNIT THAT IS SUBJECT TO A SEPARATE INJURY REPORT. OVER THE FOLLOWING YEAR, I CONTINUED TO HAVE DIFFICULTY WITH KNEE FUNCTION AND ON (B)(6) 2005, 14 MONTHS AFTER MY FIRST SURGERY, I HAD SURGERY CONSISTING OF ARTHROSCOPIC CHONDROPLASTY OF THE PATELLA, MEDIAL FEMORAL CONDYLE, AND SYNOVECTOMY OF THE PERIPATELLAR REGION. IT WAS NOTED THAT I HAD DEVELOPED GRADE III CHONDROMALACIA OF THE PATELLA AND GRADE I CHONDROMALACIA OF THE FEMORAL TROCHLEA. A SUBSEQUENT MRI ON (B)(6) 2006, TWO YEARS AFTER MY INITIAL SURGERY, NOTED THAT FINDINGS WERE SUSPICIOUS OF OSTEONECROSIS OR OSTEOCHONDRITIS DISSECANS. "CHONDROMALACIA IS SEEN IN THREE KNEE COMPARTMENTS AND MOST SERIOUSLY IN THE PATELLOFEMORAL COMPARTMENT". ON (B)(6) 2007, AN MRI AND BONE SCAN FINDINGS WERE CONSISTENT WITH AVASCULAR NECROSIS WITH SEVERE DEGENERATIVE CHANGES, FULL-THICKNESS CARTILAGE LOSS IN THREE AREAS, SEVERE THINNING OF CARTILAGE IN TWO AREAS, AND PATCHY BONE MARROW EDEMA. ACL GRAFT APPEARS INTACT BUT THERE IS AN AREA OF ARTHROFIBROSIS. THE RAPID LOSS OF CARTILAGE IS INDICATIVE OF MANY SIMILAR REPORTS OF CHONDROLYSIS ASSOCIATED WITH PAIN PUMPS THAT I RECENTLY LEARNED ABOUT. THE FDA DID NOT APPROVE OF PAIN PUMPS TO BE INSERTED INTO JOINT SPACES AND, IN FACT, ON 3 SEPARATE OCCASIONS, DENIED THE MANUFACTURER PERMISSION TO MARKET THE DEVICE FOR INTRA-ARTICULAR USE.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED ON 07/01/2016 FROM REPORTER FOR MW5037531: THIS IS A SUPPLEMENT TO A PREVIOUS (B)(6) 2014 REPORT, IN WHICH (B)(6) Y/O FEMALE, MISTAKENLY IDENTIFIED THE PAIN PUMP CAUSING HER INJURY AS AN I-FLOW DONJOY PAINBUSTER PAIN PUMP. IN FACT, IT HAS RECENTLY BEEN LEARNED THAT THE PAIN PUMP WAS A MCKINLEY/DONJOY PAIN CONTROL DEVICE ["PCD"].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441554 DONJOY I-FLOW "PAINBUSTER PAIN PUMP 100ML PAIN PUMP MEB DJO LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 17 DA Hospitalization| R| S