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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 07/15/2015

Event Type  Injury  

Manufacturer Narrative

Upon reviewing data for invoicing, project manager noticed subject had reported they had a tka (b)(6) 2015 on their 1 year follow-up questionnaire.Project manager contacted site to verify if this report was correct and to withdraw the subject.Summary: this complaint was identified through review of case report forms (crfs) submitted by the surgeons site as part of the (b)(6) study.At this time, information on the patient and revision procedure are limited to the information contained in the submitted crfs.The patient is a female, age (b)(6) at the time of the procedure.The patient underwent subchondroplasty of the medial femoral condyle to implant 5 cc's of accufill material into a bone marrow lesion on (b)(6) 2015.The patient reported minimal improvement in pain at one month after the procedure and then worsening of pain at 3 and 6 months.The patient reported no improvement in ikdc subjective scores (pain and function) at one month and then worsening in ikdc scores at 3 and 6 months.The patient underwent a knee arthroplasty on (b)(6) 2015.At the time of this report, no imaging, clinic notes or surgical documentation is available to review.The potential causes of the clinical symptoms leading to increased pain and decreased function reported by the patient and the reasons for knee arthroplasty cannot be determined.The status of the accufill implant material and surgical site also cannot be determined.Device not returned.

Event Description

Upon clinical data review.

Event Description

It was reported that a patient enrolled in a clinical study underwent subchondroplasty of the medial femoral condyle on (b)(6) 2015.During a review of the patient's one-year follow-up questionnaire, the study's clinical project manager discovered the patient underwent a total knee arthroplasty procedure on (b)(6) 2015.The patient was subsequently withdrawn from the clinical study.

• Brand Name: ACCUFILL 5CC
• Type of Device: FILLER BONE VOID, CALCIUM COMPOUND
• 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: victor krone ; 841 springdale drive; exton, PA 19341 ; 4848794224
• MDR Report Key: 5810038
• MDR Text Key: 50712696
• Report Number: 3008812173-2016-00014
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• 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: 07/22/2016

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 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: 06/20/2016
• Initial Date FDA Received: 07/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: No
• 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: 58 YR