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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. SUBCHONDROPLASTY SCP KIT

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ZIMMER KNEE CREATIONS, INC. SUBCHONDROPLASTY SCP KIT Back to Search Results
Model Number N/A
Device Problem No Apparent Adverse Event (3189)
Patient Problem Thrombosis (2100)
Event Date 03/06/2018
Event Type  Injury  
Manufacturer Narrative

This report is being submitted as a result of an adverse event from a clinical study. Deep vein thrombosis was reported as possibly related to the scp procedure and product. When additional information becomes available regarding the event, a follow-up report will be submitted.

 
Event Description

Patient had a dvt after scp.

 
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Brand NameSUBCHONDROPLASTY
Type of DeviceSCP KIT
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 Key7433119
MDR Text Key105561481
Report Number3008812173-2018-00016
Device Sequence Number1
Product Code OJH
Combination Product (Y/N)N
PMA/PMN NumberPN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/04/2018,05/14/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/16/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/02/2020
Device MODEL NumberN/A
Device Catalogue Number414.502
Device LOT NumberKC04441
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Report TO Manufacturer04/04/2018
Date Manufacturer Received04/04/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/05/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 04/16/2018 Patient Sequence Number: 1
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