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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. CPLT KNEE KIT 5CC 11G SIDE SCP KIT

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ZIMMER KNEE CREATIONS, INC. CPLT KNEE KIT 5CC 11G SIDE SCP KIT Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Loss of Range of Motion (2032)
Event Date 05/20/2019
Event Type  Injury  
Manufacturer Narrative

On (b)(6) 2018, the patient underwent a right knee athroscopy, lysis of adhesions anterior notch adhesions manipulated under anesthesia, and a subchondroplasty. There were no intraoperative complications reported. On (b)(6) 2019, zimmer knee creations was notified that a patient had returned for treatment of decreased range of motion on (b)(6) 2019. The onset date was (b)(6) 2019, and the event was marked as resolved on (b)(6) 2019. It was noted that the subject did not gain any more motion over 20 degrees. The patient had previously reported that it was hard for them to stand due to their right knee. The product was not returned for the investigation, as it remains implanted in the patient. Once additional information becomes available about the event, a supplemental report will be submitted.

 
Event Description

Clinical study subject (b)(6) experienced decreased range of motion after scp.

 
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Brand NameCPLT KNEE KIT 5CC 11G SIDE
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
leo munar
841 springdale drive
exton, PA 19341
4848794553
MDR Report Key8995462
MDR Text Key159122397
Report Number3008812173-2019-00043
Device Sequence Number1
Product Code OJH
Combination Product (Y/N)N
Reporter Country CodeUS
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 01/28/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/11/2019
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
Device LOT NumberKC05347
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/20/2019
Device Age1 mo
Event Location Hospital
Date Manufacturer Received08/13/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/09/2018
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: 09/11/2019 Patient Sequence Number: 1
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