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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 Inadequate Pain Relief (2388)
Event Date 06/19/2018
Event Type  Injury  
Manufacturer Narrative
On (b)(6) 2018, a clinical study patient underwent the scp procedure on their right cuboid; there were no complications reported intra-operatively. After the six month follow up, the subject reported an increase in pain from the baseline of "4" to a "5. " an mri was performed on (b)(6) 2018, which showed a decreased edema. The subject was prescribed a tens unit on (b)(6) 2018 for pain. Event is on-going. The device was not returned for investigation, as it remains implanted in the patient. If additional information is available, a supplemental will be submitted.
 
Event Description
Clinical subject (b)(6) pain score increased after scp surgery.
 
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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 Key8196002
MDR Text Key131393405
Report Number3008812173-2018-00041
Device Sequence Number1
Product Code OJH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2020
Device Model NumberN/A
Device Catalogue Number402.203
Device Lot NumberKC05031
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/07/2018
Device Age8 MO
Event Location Hospital
Date Manufacturer Received12/07/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/04/2018
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: 12/26/2018 Patient Sequence Number: 1
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