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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 Problem Host-Tissue Reaction (1297)
Event Date 06/29/2017
Event Type  Injury  
Manufacturer Narrative

The complainant alleged that a large lesion developed around the implantation site of scp. X-ray images were provided and will be reviewed by a health care professional during the investigation. Once additional information is obtained, a follow-up report will be submitted regarding the results of the investigation.

 
Event Description

Patient developed lession at the site of scp.

 
Manufacturer Narrative

The x-ray images provided were reviewed by a health care professional during the investigation and showed a high density bright region in the area of surgical injection surrounded by a lesion or cystic area of low bone density. Although standard procedure is to inject all 5cc's of accufill, it was noted that it was a large amount of material for a small treatment area, hindering the ability of the bsm to be resorbed and incorporated easily.

 
Event Description

Patient developed lesion at the site of 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 Key7373367
MDR Text Key103554349
Report Number3008812173-2018-00010
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,Followup
Report Date 04/18/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/27/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number414.502
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 Other
Date Manufacturer Received03/08/2018
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: 03/27/2018 Patient Sequence Number: 1
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