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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 No Apparent Adverse Event (3189)
Patient Problems Host-Tissue Reaction (1297); Inadequate Pain Relief (2388)
Event Date 02/24/2018
Event Type  Injury  
Manufacturer Narrative

A patient returned to the surgeon after the scp case with a hematoma after possible extravasation near the site of the surgery. Images were taken but not available for review. Per the investigation, it was determined that the patient did not follow post-operative instructions from surgeon, resulting in the complaint condition.

 
Event Description

Patient developed hematoma after scp of the talus.

 
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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 Key7397405
MDR Text Key104382568
Report Number3008812173-2018-00012
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 COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 04/03/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/04/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/25/2020
Device MODEL NumberN/A
Device Catalogue Number514.303
Device LOT NumberKC04137
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 Received03/23/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/12/2017
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: 04/04/2018 Patient Sequence Number: 1
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