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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 Patient Problem/Medical Problem (2688)
Event Date 09/17/2018
Event Type  Injury  
Manufacturer Narrative
Clinical subject underwent scp surgery on (b)(6) 2017. Corticosteroid injections were given to the subject on (b)(6) 2017. On (b)(6) 2018, the subject progressed to a total knee replacement. The device was not returned for the investigation, as it remains implanted in the patient. In an effort to be conservative, this complaint will be treated as a serious injury and will be investigated further. If additional information becomes available, a supplemental report will be submitted.
 
Event Description
Clinical subject (b)(6) underwent tka after scp.
 
Manufacturer Narrative
On january 17th, 2019, an adverse event form for the event was received from the clinical project lead stating that the responsible health care professional for the event determined the tka was not related to the procedure or process.
 
Event Description
Clinical subject (b)(6) underwent tka after 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 Key8199650
MDR Text Key131507996
Report Number3008812173-2018-00042
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
Report Date 01/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Hospital
Date Manufacturer Received12/05/2018
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: 12/27/2018 Patient Sequence Number: 1
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