MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE METS DISTAL FEMUR - FEMORAL STEM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_STM

Device Problems Unstable (1667); Loss of Osseointegration (2408)

Patient Problems Pain (1994); Injury (2348); Inadequate Osseointegration (2646); Cancer (3262)

Event Date 07/24/2020

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.Device not returned.

Event Description

Patient has presented with an unstable distal femoral replacement.Loosened stanmore mets distal femur.Patient specific prescription form notes: "would prefer an adapter that would allow the stanmore dfr to link up with a [competitor] spindle.If that is impossible, we will require a press-fit stem and also potentially a total femur as a backup.".

Event Description

Patient has presented with an unstable distal femoral replacement.Loosened stanmore mets distal femur.Patient specific prescription form notes: "would prefer an adapter that would allow the stanmore dfr to link up with a [competitor] spindle.If that is impossible, we will require a press-fit stem and also potentially a total femur as a backup.".

Manufacturer Narrative

Reported event: an event regarding loosening involving a mets distal femur replacement, femoral stem 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 clinical consultant indicated: the implant in situ was for a mets distal femoral replacement which was inserted in 2017.The surgeon reported that the implant has loosened.The ct scan provided shows that the bone had massive bone resorption and remodelling, and there was severe radiolucency around the stem.Therefore, the radiographic review can confirm the reason for revision.Device history review: could not be performed as lot / batch code information was not provided.Complaint history review: could not be performed as lot/ batch code information was not provided.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, pathology 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.

• Brand Name: METS DISTAL FEMUR - FEMORAL STEM
• 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; UK WD6 3SJ
• MDR Report Key: 10434944
• MDR Text Key: 203832616
• Report Number: 3004105610-2020-00131
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K121029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• 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
• Date Manufacturer Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 77