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

Catalog Number UNK_STM

Device Problem Failure to Advance (2524)

Patient Problem Cancer (3262)

Event Date 09/05/2019

Event Type  malfunction  

Manufacturer Narrative

Reported event: an event regarding seizing involving a jts proximal tibia was reported.The event was confirmed by medical review.Method and results: product evaluation and results: not performed as the device remained in situ.Clinician review:"the implant in situ was for a jts proximal tibia replacement, which was inserted in 2016.The surgeon originally reported that the implant has failed to extend but after few attempts the surgeon has managed to extend the implant.Compared with the imaging before and after the recent extension, an additional 3mm has been extended.Therefore, the original issue has been solved and no further actions is required." product history review: review of the product history records indicate 1 device were manufactured and accepted into final stock on 20 jul 2016 with no reported discrepancies.Complaint history review: there have been 4 other events.Conclusions: an event regarding seizing involving a jts proximal tibia was reported on the (b)(6) 2019.An update received on the 26sep2019 stated that the jts drive unit was boosted, allowing the surgeon to lengthen the device.The clinician review confirmed this.The exact cause of the event could not be determined further information such as the primary operative report as well as patient history and follow up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and/or insufficient information was received by siw.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be re-opened.Device not returned.

Event Description

It is reported by a surgeon that pin 20246 is not lengthening properly.Update 03oct19 - update from sales rep on (b)(6) 2019 i saw the patient yesterday with the surgeon and we boosted the mle and were successful in lengthening this implant.

• Brand Name: PROXIMAL TIBIA 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
• Manufacturer (Section G): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; GB WD6 3SJ
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; GB WD6 3SJ ; 2082386500
• MDR Report Key: 10097423
• MDR Text Key: 195394947
• Report Number: 3004105610-2020-00095
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 20246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 12 YR