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

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.".

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.".

Manufacturer Narrative

On initial receipt of the reported event, the event description was reviewed and with the limited information available at that time, a decision was made to report the event.The investigation confirmed that this unit was functional and did not cause or contribute to the reported event.The event is therefore, not reportable.

• Brand Name: JTS DRIVE UNIT
• 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; GB WD6 3SJ
• MDR Report Key: 9353804
• MDR Text Key: 189991232
• Report Number: 3004105610-2019-00122
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_STM
• Device Lot Number: 907-110
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/06/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 01/06/2020
• Supplement Dates FDA Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 14 YR