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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 Problems No Apparent Adverse Event (3189); Insufficient Information (3190)
Patient Problems Inadequate Pain Relief (2388); No Information (3190)
Event Date 10/26/2017
Event Type  Injury  
Manufacturer Narrative

This complaint is driven from a clinical study. Additional information was received on january 26th 2018 that the hcp stated the adverse event has a remote possibility or is possibly related to the study procedure. In an effort to be conservative, this complaint will be treated as a serious injury and will be investigated further.

 
Event Description

Subject has a tka after scp procedure that was reported through an adverse event form stemming from a clinical study.

 
Manufacturer Narrative

Patient returned for care 6 weeks post-op. Physician confirmed in clinical notes that the patient has seen improvements since before her scp surgery and is capable of full range of motion, but still continued to feel some pain and had difficulty fully extending her knee and bearing weight. She was treated with cortisone injections.

 
Event Description

Subject has a tka after scp procedure that was reported through an adverse event form stemming from a clinical study.

 
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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 Key7271566
MDR Text Key100117661
Report Number3008812173-2018-00005
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 HEALTH PROFESSIONAL,STUDY
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/06/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/14/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
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 Hospital
Date Manufacturer Received01/16/2018
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: 02/14/2018 Patient Sequence Number: 1
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