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

Catalog Number JTS-DRIVE-UNIT

Device Problem Failure to Advance (2524)

Patient Problem Insufficient Information (4580)

Event Date 02/22/2022

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Failed lengthening reported.

Event Description

Failed lengthening reported.

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).Reported event: the reported device is a jts drive unit, sn: (b)(6).Method & results: device evaluation and results: visual inspection: visual inspection of the jts coil reported, showed overall general wear and tear on the product.Both the magnetic coil and the power unit console share the same serial number ¿(b)(6)¿ and both devices state the date of manufacture is ¿mar 2014¿.Dimensional inspection: not performed as not relevant to the reported event.Functional inspection: the drive unit mle3 lot: (b)(6) passed the annual maintenance/ function test.Material analysis: not performed as not relevant to the reported event.Clinician review: n/a.Device history review: review of the annual maintenance and functional inspection indicates the device conformed to requirements.Complaint history review: there have been no other events.Conclusion.The jts drive unit ((b)(6)) passed its annual maintenance test, confirming that drive unit is working accordingly.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, pathology reports, progress notes, x-rays and return of the device are needed to fully investigate the event.

• Brand Name: JTS DRIVE UNIT SET
• Type of Device: PROSTHESIS, 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, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 13768196
• MDR Text Key: 288908961
• Report Number: 3004105610-2022-00026
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: JTS-DRIVE-UNIT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other