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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 08/03/2016

Event Type  Death  

Manufacturer Narrative

Information was gathered verbally during a phone conversation between dr.(b)(6) on (b)(6) 2016.Dr.(b)(6) was the surgeon involved in this complaint.The patient was a (b)(6) female presenting with knee pain.The patient did not wish to have a knee replacement.Dr.(b)(6) performed a subchondroplasty procedure of the medial femoral condyle and medial tibial plateau.He estimated that 15 cc's of accufill material was injected into the medial femoral condyle and 10 cc's was injected into the medial tibial plateau.No significant fluctuations in heart rate or blood pressure were noted during the injection.Dr.(b)(6) then waited 15 minutes for the accufill to harden before proceeding with the knee arthroscopy.He estimated that the arthroscopy then took 20-25 minutes to complete.At the completion of the arthroscopy (approximately 35 minutes after the accufill injection), the patients heart rate and blood pressure began to drop.The patient suffered a massive heart attack though to be caused by an acute infarct.The hospital coroner did not recommend an autopsy and the family did not request one.Dr.(b)(64) did not believe that the heart failure was related to the injection of accufill due to the timing of the event being so long after the injection.Dr.(b)(6) mentioned that during prior cases he has seen a slight drop in heart rate during injection of the accufill material, but did not observe that in this case.Relationship between the injection of the accufill material and the heart failure experienced by this patient cannot be confirmed or ruled out due to the absence of an autopsy.Not explanted.

Event Description

Patient expired on table after scp procedure.

• Brand Name: ACCUFILL 5CC
• Type of Device: CALCIUM PHOSPHATE 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: victor krone ; 841 springdale drive; exton, PA 19341 ; 4848794224
• MDR Report Key: 5916109
• MDR Text Key: 53547986
• Report Number: 3008812173-2016-00015
• 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: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/30/2016

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: 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: 08/09/2016
• Initial Date FDA Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 92 YR