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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE JTS DRIVE UNIT PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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STANMORE IMPLANTS WORLDWIDE JTS DRIVE UNIT PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number UNK_STM
Device Problems Use of Device Problem (1670); Insufficient Information (3190)
Patient Problems No Known Impact Or Consequence To Patient (2692); Cancer (3262)
Event Date 09/06/2019
Event Type  malfunction  
Manufacturer Narrative
Please note that this event is related to a jts drive unit which is used in conjunction with the jts non-invasive extendible implant (k092138). An investigation is being performed in an attempt to identify the cause of the event. Should additional information become available it will be reported in a supplemental report.
 
Event Description
This pi is created for the first attempt last 25 of august. It is reported " first attempt has been performed with no success last 25 of august with power unit set on 0. Second attempt today. " additional notes state "center is exposed to jts system, never got problems before. Same skilled physician as in the past. It has been tried several time the unlocking procedure to switch from b to a. Power unit set on 3 and 4. Implant sounded as locked, sounded working going reverse (b) and then going ahead (a) but just for a few seconds. ".
 
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Brand NameJTS DRIVE UNIT
Type of DevicePROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
STANMORE IMPLANTS WORLDWIDE
210 centennial avenue
centennial park, elstree
borehamwood WD6 3 SJ
GB WD6 3SJ
Manufacturer (Section G)
STANMORE IMPLANTS WORLDWIDE
210 centennial avenue
centennial park, elstree
borehamwood WD6 3 SJ
GB WD6 3SJ
Manufacturer Contact
diana rogers
210 centennial avenue
centennial park, elstree
borehamwood WD6 3-SJ
GB   WD6 3SJ
2082386500
MDR Report Key9353804
MDR Text Key189991232
Report Number3004105610-2019-00122
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_STM
Device Lot Number907-110
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/06/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 11/21/2019 Patient Sequence Number: 1
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