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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 11/13/2014
Event Type  Injury  
Manufacturer Narrative

This complaint is driven from a clinical study; a total knee replacement surgery took place after the scp procedure. The hcp stated the ae has a remote possibility it is related to the device. In an effort to be conservative, this complaint will be treated as a serious injury and will be investigated further.

 
Event Description

Tka after scp clinical study subject.

 
Manufacturer Narrative

Additional information about the initial scp surgery was unable to be obtained, as the name of doctor who performed the initial scp surgery was not provided to the doctor who performed the tka. Although, the operative notes state the patient also had a medial meniscus tear, probable lateral meniscus tear, tricompartmental chondrosis and a medial tibial plateau stress fracture. He understood that he would need arthroplasty as some point, but would like to delay the procedure.

 
Event Description

Tka after (b)(6) clinical study subject.

 
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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 Key7120538
MDR Text Key94941267
Report Number3008812173-2017-00028
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 HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 03/01/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/15/2017
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 Received11/30/2017
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 NumberN/A

Patient TREATMENT DATA
Date Received: 12/15/2017 Patient Sequence Number: 1
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