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 10/05/2011

Event Type  Injury  

Manufacturer Narrative

Investigation is still in-progress.This complaint stems from a clinical study data review.

Event Description

Clinical subject (b)(6) revision surgery.

Manufacturer Narrative

A review was done of the documentation attached; a basic timeline is provided below: ¿ (b)(6) 2013: left knee arthroscopy ¿ in patella, ¿fully rehabbed and somewhat improved¿.¿ (b)(6) 2013: right knee arthroscopy.¿ (b)(6) 2013: adverse event form for trouble with dorsiflexion, neurologist test, evidence suggestive of a left peroneal neuropathy at fibular head.¿ (b)(6) 2014: adverse event form for cartilage defect, noted as not related to study or study device.Follow up surgery on left knee for cartilage defect of patella.The patient, after receiving a patellar scp, had difficulty flexing their left foot up.She has a neuro consult with emg and ncv.Their interpretation of the results was that the patient had ¿left peroneal neuropathy at the fibular head¿.No indication was made in the report or follow up latter that this could have been caused by the subchondroplasty done to the patella.The adverse event form indicated that the event was resolved as of (b)(6) 2013 (1 month later).The cause of this adverse event is unknown, but from this investigation, it is not likely to have been caused by the subchondroplasty procedure.The patient also presented with persistently symptomatic patella cartilage defects before the scp procedure.This culminated in a parapatella arthrotomy surgery in (b)(6) 2014.This was indicated by the adverse event tracking lot as being not related to the subchondroplasty procedure.The cause of this adverse event is unknown, but from this investigation, it most likely stemmed from the indicated preexisting condition.

Event Description

Clinical subject (b)(4) revision surgery: dr.(b)(6) reported a persistently symptomatic patellar cartilage defect as of (b)(6) 2011, prior to subchondroplasty procedure.This event worsened in severity and ultimately required an additional surgical intervention on of autologous chondrocyte implantation to the patella on (b)(6) 2014; it was not related to the procedure or to the study device.During a post-operative clinic visit on (b)(6) 2014, dr.(b)(6) deemed the adverse event 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: 6114080
• MDR Text Key: 60377733
• Report Number: 3008812173-2016-00027
• 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; Required Intervention
• Patient Age: 29 YR
• Patient Weight: 75