MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. 201.050; CALCIUM PHOSPHATE COMPOUND BONE VOID FILLER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

This investigation is still in-progress.A supplemental mdr will be submitted when investigation is completed.

Event Description

Pateint received scp developed dvt.

Manufacturer Narrative

No further information has been able to be obtained after several attempts to contact the doctor / doctors office / sales team.In a review of prior complaints of this nature, doctors consulted as medical experts in complaint # (b)(4)/ mdr#30088121173-2014-00001): "dvt and pulmonary embolism are recognized post-operative complications of knee arthroscopy occuring with a 0.25-9.9% of deep venous thrombosis and a 0.17% incidence of pulmonary embolism usually presenting 4-21 days after surgery" (b)(4).

Event Description

Pateint received scp developed dvt.

• Brand Name: 201.050
• 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: 6141998
• MDR Text Key: 61344395
• Report Number: 3008812173-2016-00031
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 03/28/2017

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/02/2016
• Initial Date FDA Received: 12/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/28/2017
• 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