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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 Pain (1994); No Information (3190)
Event Date 11/18/2014
Event Type  Injury  
Manufacturer Narrative

This complaint is driven from a clinical study; the patient received an osteochondral allograft after receiving scp. The hcp stated the ae was possibly related to the device and procedure. In an effort to be conservative, this complaint will be treated as a serious injury and will be investigated further.

 
Event Description

Clinical subject received osteochondral allograft after scp.

 
Manufacturer Narrative

Per investigation of the operative notes, the patient reported she was doing acceptably well until she fell. The fall had caused increase pain and the need for an additional surgery.

 
Event Description

Clinical subject received osteochondral allograft 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 Key7118206
MDR Text Key94870949
Report Number3008812173-2017-00029
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 03/06/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/14/2017
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 Received12/01/2017
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: 12/14/2017 Patient Sequence Number: 1
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