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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 Biological Environmental Factor (2887)
Patient Problems Host-Tissue Reaction (1297); Inadequate Pain Relief (2388)
Event Date 01/29/2018
Event Type  Injury  
Manufacturer Narrative

Patient returned about one month after the scp procedure with complaints of increased pain, and radiographs appeared normal. The patient returned on (b)(6) with continued pain and x-rays showed concern of possible stress fracture. On (b)(6) the stress fracture was confirmed by a ct. A follow-up report will be submitted with the results of the investigation.

 
Event Description

Clinical study subject received scp and presented with a possible stress fracture.

 
Manufacturer Narrative

Operative notes from the case were received and indicate that the procedure occurred without any adverse events; however, changes from grade 2 to grade 4 were noted in the medial cartilage and grade 0 in lateral compartment that attributed to the complaint condition.

 
Event Description

Clinical study subject received scp and presented with a possible stress fracture.

 
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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 Key7403915
MDR Text Key104597911
Report Number3008812173-2018-00015
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,STUDY
Type of Report Initial,Followup
Report Date 05/14/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/06/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/07/2020
Device MODEL NumberN/A
Device Catalogue Number414.502
Device LOT NumberKC04323
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location Outpatient Treatment Facility
Date Manufacturer Received03/14/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/15/2017
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: 04/06/2018 Patient Sequence Number: 1
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