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

Catalog Number UNK_STM

Device Problems Malposition of Device (2616); Osseointegration Problem (3003); Insufficient Information (3190)

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

Event Date 10/24/2019

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.Device not returned.

Event Description

Revision surgery : order for implant + handpiece."replacement of the tibial piece (tibial reconstruction) of a stanmore prosthesis","right",date of revision : (b)(6) 2019.Update: the customer replied: " it is a tibial failure : the femoral part is perfect.However, the causes of tibial failure are primarily mechanical and have nothing to do with the implant.In fact, to be very honest, i'm trying one last reconstruction with allograft but i'm not sure what the result will be.

Manufacturer Narrative

An event regarding proximal tibia loosening of a tibial component implant mets was reported.The event was confirmed by x ray review.Method and results: product evaluation and results: not performed as no items were returned.Clinical review: x ray images were provided for review: the clinician reported the following: the implant in situ was for a mets proximal tibia replacement which the date of insertion is unknown.The surgeon has now reported aseptic loosening of the implant.The x-ray provided has shown that the tibia stem has penetrated through the bone with massive radiolucent lines along the stem and the fragmentation of the cement mantle.Therefore, the radiographic assessment can confirm the reason for revision.Product history review: a review of the product history records could not be performed as this device does not have a lot id.Complaint history review: a complaint history review could not be performed as this device does not have a lot id.Conclusions: the exact cause of the event could not be determined because further information such as identification of the device, the device catalogue and the device lot, the primary operative report as well as additional 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.

Event Description

Revision surgery : order for implant + handpiece."replacement of the tibial piece (tibial reconstruction) of a stanmore prosthesis""right" date of revision : (b)(6) 2019.Update 05nov19 - , "tibial failure" is due to aseptic loosening, the femoral part is perfect.

• Brand Name: UNKNOWN METS 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: 9348039
• MDR Text Key: 169276743
• Report Number: 3004105610-2019-00121
• 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: 02/11/2020

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 Catalogue Number: UNK_STM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/20/2019
• Supplement Dates Manufacturer Received: 01/29/2020
• Supplement Dates FDA Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR