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

Model Number PIN 20192

Device Problem Unclear Information (4052)

Patient Problems Injury (2348); Inadequate Osseointegration (2646)

Event Date 06/15/2018

Event Type  Injury  

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.Unknown if the device will be returned.

Event Description

It was reported a revision due to loosening to take place.

Manufacturer Narrative

Corrected information: the device name has been corrected from proximal tibia to proximal tibia jts an event regarding alleged loosening involving a jts proximal tibia femoral component was reported.A review of the provided x-rays by a clinical consultant concluded "the x-ray provided shows that the tibial stem is well fixed.The femoral stem is smaller than the diameter of the canal which could be due to the growth of the patient in these two years.The femoral stem is a passive fixation which might cause the sliding movement of the stem within the canal, other than this the femoral stem is well positioned inside the canal.The reported incident cannot be radiographically confirmed as it is not showing the movement of the stem." the exact cause of the event could not be determined because 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 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 returned.

Event Description

It was reported a revision due to loosening to take place.

• Brand Name: PROXIMAL TIBIA
• 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
• MDR Report Key: 7680745
• MDR Text Key: 113741685
• Report Number: 3004105610-2018-00059
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K140898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2017
• Device Model Number: PIN 20192
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 20192
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR
• Patient Weight: 49