MAUDE Adverse Event Report: DJO LLC DONJOY I-FLOW "PAINBUSTER PAIN PUMP 100ML

Catalog Number I1-1349-0-0000

Device Problem Insufficient Information (3190)

Patient Problems Edema (1820); Necrosis (1971); Injury (2348); Fibrosis (3167)

Event Date 10/15/2004

Event Type  Injury  

Event Description

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.

Event Description

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"].

• Brand Name: DONJOY I-FLOW "PAINBUSTER PAIN PUMP 100ML
• Type of Device: PAIN PUMP
• Manufacturer (Section D): DJO LLC
• MDR Report Key: 3972984
• MDR Text Key: 18092159
• Report Number: MW5037531
• Device Sequence Number: 1
• Product Code: MEB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: I1-1349-0-0000
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/29/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/30/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 17 DA
• Patient Weight: 64