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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 Appropriate Term/Code Not Available (3191)
Patient Problems Pulmonary Embolism (1498); Thrombosis (2100)
Event Date 02/18/2019
Event Type  Injury  
Manufacturer Narrative

Communication was received from a sales representative that a patient developed an dvt/pe after subchondroplasty. The product information and details of the event are unknown at this time. A supplemental report will be submitted once additional information is obtained regarding the event.

 
Event Description

Patient developed dvt/pe after subchondroplasty.

 
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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 Key8438076
MDR Text Key139410670
Report Number3008812173-2019-00013
Device Sequence Number1
Product Code OJH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberUNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/22/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/20/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue NumberUNKNOWN
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/18/2019
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 NumberN/A

Patient TREATMENT DATA
Date Received: 03/20/2019 Patient Sequence Number: 1
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