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

Catalog Number UNK_STM

Device Problem Failure to Advance (2524)

Patient Problems No Known Impact Or Consequence To Patient (2692); Cancer (3262)

Event Date 05/04/2020

Event Type  malfunction  

Manufacturer Narrative

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.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Device not returned.

Event Description

As reported: "surgeon is reporting that the patient's [right side] jts device (stanmore pin 20350) is not lengthening.Device was reportedly lengthening fine for 3+ years (35mm) after surgery.Surgeon said that all of a sudden, they went to lengthen him, everything sounded fine, then all of a sudden the noise audibly changed, and the gearbox seemed to stop running.Walking with slight limp due to leg length discrepancy.".

Event Description

As reported: "surgeon is reporting that the patient's [right side] jts device (stanmore pin 20350) is not lengthening.Device was reportedly lengthening fine for 3+ years (35mm) after surgery.Surgeon said that all of a sudden, they went to lengthen him, everything sounded fine, then all of a sudden the noise audibly changed, and the gearbox seemed to stop running.Walking with slight limp due to leg length discrepancy.".

Manufacturer Narrative

Reported event: an event regarding seizing involving a jts, distal femur, extension mechanism was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as device remains implanted.Clinician review: no medical records were received for review with a clinical consultant.Device history review: review of the product history records indicate 1 device was manufactured and accepted into final stock on 27 oct 2016 with no reported discrepancies.Complaint history review: there have been 3 other events.Conclusion: on the (b)(6) 2020, the sales reported that as a result of the unsuccessful lengthening, on the (b)(6) 2020, the surgeon tried another lengthening procedure with a boosted magnet.On the same day the sales rep reported that lengthening procedure was successful.The exact cause of the prior unsuccessful lengthening could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return 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: DISTAL FEMUR JTS
• 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: 10106724
• MDR Text Key: 194141637
• Report Number: 3004105610-2020-00097
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K133152
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 20350
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 14 YR