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U.S. Department of Health and Human Services

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

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STANMORE IMPLANTS WORLDWIDE JTS DRIVE UNIT SET PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number JTS-DRIVE-UNIT
Device Problem Failure to Advance (2524)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/07/2022
Event Type  malfunction  
Event Description
As reported: "the magnet did not lengthen the implant. It was making the normal sound like it was working, but after x-ray confirmation, it showed no lengthening. They tried a second time and again, no change on x-ray. " spoke to rep. The rep was not onsite for the attempted lengthening, but she had sent an email with pictures explaining all of the correct steps for a lengthening, including using the direction as reported in the design proposal and aligning the external and internal magnets. Rep had asked the site if they had boosted the unit. The site reported the unit was set to 4, which is ineffectual, so the rep asked them to attempt at setting 3. Lengthening again failed. Site reported that the drive unit was making a whirring sound, but it was not as audible as experienced in the past. Surgeon wants to obtain another drive unit to lengthen the existing implant.
 
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) should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
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Brand NameJTS DRIVE UNIT SET
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
UK WD6 3SJ
Manufacturer (Section G)
STANMORE IMPLANTS WORLDWIDE
210 centennial avenue
centennial park, elstree
borehamwood WD6 3 SJ
UK WD6 3SJ
Manufacturer Contact
diana rogers
210 centennial avenue
centennial park, elstree
borehamwood WD6 3-SJ
UK   WD6 3SJ
2082386500
MDR Report Key14235621
MDR Text Key290376585
Report Number3004105610-2022-00062
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 04/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberJTS-DRIVE-UNIT
Device Lot Number907-502
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 04/28/2022 Patient Sequence Number: 1
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