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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/05/2022

Event Type  malfunction  

Event Description

It has been reported there was a failed lengthening.On (b)(6) 2022 another lengthening is scheduled with the same drive unit.Update (b)(6) 2022 the lengthening on (b)(6) 2022 was successful.

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).It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It has been reported there was a failed lengthening.On (b)(6) 22 another lengthening is scheduled with the same drive unit.Update (b)(6) 22 the lengthening on (b)(6) 22 was successful.

Manufacturer Narrative

Reported event: an event regarding non functionality involving a jts, drive unit was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device history review: review of the annual maintenance and functional inspection indicates the device successfully passed functional inspection.No comments/ observations.Complaint history review: there have been no other events for the lot referenced.Conclusion: the investigation concluded that the unsuccessful lengthening procedure reported on the (b)(6) 22 was caused by improper seating of the patient leg, on the (b)(6) 2022 it was reported that the second lengthening attempt was successful they stated" [.] apparently, the patient leg was not placed properly inside the magnetic coil: reason of the failure.It works well the second time." a review of the lengthening protocol & operation manual, noted the following: in the section titled "patient positioning" it states "[.] the patient should be positioned comfortably sitting in a chair with their hips the same height as the center of the magnetic coil [.] please use proper cushioning so that the patient¿s limb is adequately supported during the lengthening [.]".No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• 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 WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 14526666
• MDR Text Key: 296872615
• Report Number: 3004105610-2022-00085
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• 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: 907-234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2022
• 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 Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 15 YR
• Patient Sex: Male