MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR - PASSIVE TIBIAL COMPONENT; 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 02/17/2020

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.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

As reported by sales business manager: "a patient had a stanmore distal femur replacement approximately 7 years ago.Needs to revise his passive tibial component.He does not wish to revise the femoral implant and so we need to know what tibial components/ stems/ bushings etc will be compatible with the implant he already has in situ." reason for revision: loosening of the tibial stem.

Manufacturer Narrative

Reported event: an event regarding loosening of the tibial stem involving a patient specific distal femur was reported.The event was confirmed by medical review.Method and results: product evaluation and results: not performed as no items were returned.Clinician review: the implant in situ was for a distal femoral replacement which was inserted on (b)(6) 2015.The surgeon reported that the tibial stem has loosened.The x-ray provided showed that the tibial stem is smaller than the tibial cavity in the front view and some bone resorption and bone remodelling in the lateral view of the x-ray.Therefore, the radiographic review can confirm the reason for revision.Product history review: review of the product history records indicate 1 device was manufactured and accepted into final stock on 21aug2015 with no reported discrepancies.Complaint history review: based on the device identification the complaint databases were reviewed from (b)(6) 2017 to present for similar reported events regarding loosening of the tibial stem involving patient specific distal femoral replacement.There has been 1 other event.Conclusions: an event regarding loosening of the tibial stem involving a patient specific distal femur was reported.The event was confirmed by medical review.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/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.

Event Description

As reported by sales business manager: "a patient had a stanmore distal femur replacement approximately 7 years ago.Needs to revise his passive tibial component.He does not wish to revise the femoral implant and so we need to know what tibial components/ stems/ bushings etc will be compatible with the implant he already has in situ." reason for revision: loosening of the tibial stem.

• Brand Name: DISTAL FEMUR - PASSIVE TIBIAL COMPONENT
• 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: 9834893
• MDR Text Key: 183784767
• Report Number: 3004105610-2020-00064
• 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,other
• Type of Report: Initial,Followup
• Report Date: 04/22/2020

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: PIN 19652
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/17/2020
• Initial Date FDA Received: 03/16/2020
• Supplement Dates Manufacturer Received: 04/22/2020
• Supplement Dates FDA Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 19 YR