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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/13/2018
Event Type  Injury  
Manufacturer Narrative
It was reported that approximately 1cc of accufill extravasated into the joint due to cortical perforation when the cannula was introduced. The accufill was evacuated and irrigated. The patient was awoken from anesthesia and taken back to recovery in stable condition. If additional information becomes available, an additional report will be submitted.
 
Event Description
Accufill extravasated into the joint.
 
Manufacturer Narrative
It was reported that approximately 1cc of accufill extravasated into the joint due to cortical perforation when the cannula was introduced. During the procedure on (b)(6) 2018, the surgeon perforated the contralateral cortical wall which, during the accufill injection step of the scp procedure, was the source of extravasation. The extravasated accufill was identified and removed per standard surgical technique. The procedure proceeded as anticipated and the patient remains in the clinical cohort.
 
Event Description
Accufill extravasated into the joint.
 
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Brand NameSUBCHONDROPLASTY
Type of DeviceSCP KIT
Manufacturer (Section D)
ZIMMER KNEE CREATIONS, INC.
841 springdale drive
exton PA 19341
MDR Report Key7933712
MDR Text Key122643629
Report Number3008812173-2018-00036
Device Sequence Number1
Product Code OJH
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/10/2020
Device Model NumberN/A
Device Catalogue Number514.503
Device Lot NumberKC04571
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/04/2018
Device Age11 MO
Event Location Hospital
Date Manufacturer Received09/04/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

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