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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. SUBCHONDROPLASTY SCP

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ZIMMER KNEE CREATIONS, INC. SUBCHONDROPLASTY SCP Back to Search Results
Model Number N/A
Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Host-Tissue Reaction (1297); Cyst(s) (1800); Unspecified Infection (1930)
Event Date 05/29/2018
Event Type  Injury  
Manufacturer Narrative

An email was received from a surgeon stating a patient may have experienced an infection with chronic osteomyelitis after the scp procedure, which was performed approximately three years ago. X-ray images of the area were received and will be reviewed as a part of the investigation. Once additional information becomes available, a supplemental report will be submitted.

 
Event Description

Patient appears to have developed an infection with chronic osteomyelitis as per the surgeon after receiveing scp.

 
Manufacturer Narrative

The observations and pictures reported in this complaint were documented at the time of the revision surgery. The excised section pictured in the attached intraoperative photos was sent for pathology screening and confirmed to be infected through the pathology report. The infection appears to have been related to index procedure. The patient was successfully treated by removing the accufill and treating the infection with an antibiotic laden lattice and is progressing well.

 
Event Description

Patient appears to have developed an infection with chronic osteomyelitis as per the surgeon after receiving scp.

 
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Brand NameSUBCHONDROPLASTY
Type of DeviceSCP
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 Key7621009
MDR Text Key111734124
Report Number3008812173-2018-00025
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,USER FACI
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/31/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/20/2018
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 Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/31/2018
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: 06/20/2018 Patient Sequence Number: 1
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