MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE PROXIMAL TIBIA JTS; LIMB SALVAGE SYSTEM

Catalog Number UNK_STM

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Code Available (3191)

Event Date 03/13/2019

Event Type  malfunction  

Manufacturer Narrative

An event regarding alleged failure to extend involving a jts proximal tibia was reported.The event was not confirmed.Conclusions: it is reported that the device successfully completed 4 lengthening procedures in 2015, but as the patient had a stiff knee further lengthening procedures were put on hold until (b)(6) 2019.Following approximately 3 years without extending the patient, the surgeon experienced difficulties, on the (b)(6) 2019, when lengthening the patient as the device was reported to be unable to overcome the patients scar tissue.The surgeon made an enquiry to siw to discuss options and was advised to use the boost facility of the siw drive unit in order to overcome the patient tissue.The surgeon was able to complete a successful lengthening using the boost facility.The investigation concluded that the alleged failure to extend was potentially caused by patient tissue resistance.The exact cause of the event could not be determined because further information such as pre- and post-operative x-rays and 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 insufficient information was received by siw.If devices and additional information become available to indicate further evaluation is warranted, this record will be re-opened.Siw will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.Device not available.

Event Description

It was reported, "i have a patient ((b)(6)) with a non-invasive grower (right prox tibia, (b)(6) 2014) that successfully went through 4 lengthening procedures in 2015.After that he had a stiff knee joint and we stopped the lengthening.Today i tried lengthening him again, but i seems like the mechanism is not strong enough to overcome the scar tissue.Setting the machine in position a ¿ i¿m able to start shortening.Then i pos b, i¿m just able to re-establish the length, but not proceed".

• Brand Name: PROXIMAL TIBIA JTS
• Type of Device: LIMB SALVAGE SYSTEM
• 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: margaret foley ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; GB WD6 3SJ ; 2082386500
• MDR Report Key: 8443074
• MDR Text Key: 139699558
• Report Number: 3004105610-2019-00039
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K092138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2014
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 18762
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2014
• 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: 15