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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 Device Operates Differently Than Expected (2913)
Patient Problem Host-Tissue Reaction (1297)
Event Date 05/26/2016
Event Type  Injury  
Manufacturer Narrative

This event was previously submitted on 0001825034-2018-01702. Patient stated that the ankle underwent core depression followed by ankle necrosis. Additional information about the event is pending the operative note and the investigation. Once additional information is obtained, a follow up report will be submitted.

 
Event Description

Bone filler spreading.

 
Manufacturer Narrative

The operative notes and x-rays submitted from the patient, and it was determined there was insufficient information available to determine the exact root cause of the complaint condition. Possible contributes to the complaint condition could be over filling of the material into the defect area.

 
Event Description

Bone filler spreading.

 
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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 Key7561751
MDR Text Key109818134
Report Number3008812173-2018-00022
Device Sequence Number1
Product Code OJH
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/27/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/01/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/10/2019
Device MODEL NumberN/A
Device Catalogue Number514.503
Device LOT NumberKC02804
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received02/10/2018
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: 06/01/2018 Patient Sequence Number: 1
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