MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE DISTAL FEMORAL AND PROXIMAL TIBIAL REPLACEMENT- PROXIMAL TIBIA; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_STM

Device Problem Loss of Osseointegration (2408)

Patient Problems Injury (2348); Inadequate Osseointegration (2646); Cancer (3262)

Event Date 02/19/2020

Event Type  Injury  

Manufacturer Narrative

The reported device is similar to a device approved for compassionate use in the united states.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

A patient specific implant prescription form was received reporting the following: left side.Reason for revision surgery aseptic loosening left proximal tibia epr.

Manufacturer Narrative

Reported event: an event regarding loosening involving a distal femoral replacement and proximal tibial replacement was reported.The event was confirmed by x ray review.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided x-rays by a clinical consultant indicated: the implant in situ was for a proximal tibial and distal femoral replacement which was inserted in (b)(6) 2018.The surgeon reported aseptic loosening of the implant.The ct scan provided shows some radiolucent lines along the stem between cement mantle and cortical bone and some osteolytic lesions at the tip of the stem.The same phenomenon can be observed for the femoral stem.Therefore, the radiographic review can confirm the reason for revision.Device history review: review of the product history records indicate 1 device was manufactured and accepted into final stock on 16 jan 2018 with no reported discrepancies.Complaint history review: based on the device identification the complaint databases were reviewed from 01-jan-2017 to present for similar reported events regarding patient specific / custom, proximal tibia, tibial component loosening.There has been 3 other events.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, 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.

Event Description

A patient specific implant prescription form was received reporting the following: left side.Reason for revision surgery aseptic loosening left proximal tibia epr.Update 08 april 2020: the x ray review stated loosening can be observed on the proximal tibia, as well as the femoral stem.

• Brand Name: DISTAL FEMORAL AND PROXIMAL TIBIAL REPLACEMENT- PROXIMAL TIBIA
• 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: 9834891
• MDR Text Key: 183500937
• Report Number: 3004105610-2020-00065
• 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: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 21149
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 03/16/2020
• Supplement Dates Manufacturer Received: 04/16/2020
• Supplement Dates FDA Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 42 YR