MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. ACCUFILL 5CC; CALCIUM PHOSPHATE COMPOUND BONE VOID FILLER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 11/09/2012

Event Type  Injury  

Manufacturer Narrative

This is a clinical study adverse event originated by the review of clinical data.Investigation is still in progress.Not returned.

Event Description

Clinical subject ordered (b)(4) additional surgical intervention.

Manufacturer Narrative

Independent review was conducted of the clinical documentation from the study regarding the patient condition and treatment.Per the knee follow-up report (b)(6) 2012, the patient underwent multiple knee surgeries including carticel and was still experiencing knee pain.Per the (b)(6) 2013 operative notes, the patient returned with increased pain in (b)(6) 2013.Mri confirmed at that time that the patient had medial compartment chondrosis in the femoral condyle and tibial plateau.Subchondroplasty was conducted with arthroscopy at that time.The patient returned with continued knee pain.Surgery was performed on (b)(6) 2013 - osteochondral allograft implants with subchondroplasty for the same area of the knee.In the knee post-op report (b)(6) 2013, it was reported that the patient was doing well and very pleased with the treatment.The chondrosis was reported prior to the initial subchondroplasty treatment - the patient has had multiple knee surgeries prior to the initial scp treatment.After the second scp surgery the patient was "very pleased" with her knee.Is it documented that the scp treatment was not the cause of the chondrosis.The cause of the knee pain after the initial scp surgery cannot be determined.After the second scp surgery the matter was reported as resolved.

Event Description

Clinical subject (b)(4) additional surgical intervention.Dr.(b)(6) reported extensive chondrosis mfc and mtp as well as subchondral edema/stress reaction mfc and mtp as of (b)(6) 2012, prior to subchondroplasty procedure.These events worsened to moderate severity and ultimately required an additional surgical intervention on (b)(6) 2013 of osteochondral allograft in the medial femoral condyle, as well as subchondroplasty to the medial tibial plateau; it was not related to the procedure but was possibly related to the study device.During a post-operative clinic visit on (b)(6) 2013, dr.(b)(6) deemed the adverse events to be resolved.

• Brand Name: ACCUFILL 5CC
• Type of Device: CALCIUM PHOSPHATE COMPOUND BONE VOID FILLER
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• Manufacturer (Section G): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• Manufacturer Contact: shari bailey ; 841 springdale drive; exton, PA 19341 ; 4848794543
• MDR Report Key: 6114257
• MDR Text Key: 60414944
• Report Number: 3008812173-2016-00028
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2016

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 201.050
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/20/2016
• Initial Date FDA Received: 11/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Weight: 93