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

Catalog Number JTS-DRIVE-UNIT

Device Problems Failure to Advance (2524); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2021

Event Type  malfunction  

Event Description

I worked with dr.In surgery yesterday and he informed me that on wednesday, 12/1, he had a issue with the magnet not working properly.The patient was not able to be lengthened.Right proximal tibia jts.There are no issues with the actual implant or the patient.The magnet was used on a patient the same day successfully, but the connection cord seemed to be not connecting properly per the surgeon.

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.Device not returned.

Event Description

I worked with dr.In surgery yesterday and he informed me that on wednesday, (b)(6) 2021, he had a issue with the magnet not working properly.The patient was not able to be lengthened.Right proximal tibia jts.There are no issues with the actual implant or the patient.The magnet was used on a patient the same day successfully, but the connection cord seemed to be not connecting properly per the surgeon.

Manufacturer Narrative

Reported event: an event regarding non - functionality involving a jts, drive unit was reported.The event was confirmed by product inspection.Method & results: visual inspection: visual inspection of the jts power unit reported showed some minor damage, the label on the top of the unit is visibly worn and has scratches and the casing of the unit is slightly deformed.The white connection port does appear intact.The magnetic coil also appears intact, and all labels are visible.No clear images of the connection cords were provided.Dimensional inspection: not performed as not relevant for the failure mode reported.Functional inspection: review of the annual maintenance and functional inspection (performed on (b)(6) 2021) indicates the device did not pass functional inspection, both the connection cables and leads failed testing.Under the comments / observation section it states " power is present, doesn't transfer power to coil, no rotation".Material analysis: not performed as not relevant for the failure mode reported.Device evaluation and results: clinician review: no medical records were received for review with a clinical consultant.Device history review: review of the annual maintenance and functional inspection (performed on (b)(6) 2021) indicates the device conformed to requirements.Complaint history review: there have been no other events for the lot referenced.Conclusion: on (b)(6) 2021 the manager of branch operations, texas, forwarded images of the jts drive unit and a completed annual maintenance and functional inspection (performed (b)(6) 2021).The device failed inspection due to connection issues with a cable and lead, the inspection states "[.] power is present, doesn't transfer power to coil, no rotation [.]" on (b)(6) 2022 the complaint investigator asked for a follow up on the status of the device and if a root cause had been identified.The branch manager responded "we attempted to repair the problem by changing the cables, but this did not solve the problem [.]"the branch manager confirmed the device will be sent for repair.The exact cause of the event could not be determined because insufficient information was provided.Additional information including reports, progress notes, and further inspection of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• 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: 13042084
• MDR Text Key: 282489056
• Report Number: 3004105610-2021-00163
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2022
• 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 Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 14 YR
• Patient Sex: Male