MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE FEMORAL DIAPHYSEAL REPLACEMENT - DISTAL COMPONENT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_STM

Device Problem Loss of Osseointegration (2408)

Patient Problem Inadequate Osseointegration (2646)

Event Date 01/30/2023

Event Type  Injury  

Manufacturer Narrative

The reported device is similar to a device approved for compassionate use in the united states.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.Device not returned.

Event Description

A patient specific implant request form was received for the patient's left diaphyseal femur.Noted on the form: "currently has a custom stanmore implant.This is loose.Needs to be revised.I would like to retain the proximal segment if possible, and exchange with a new stem.I envisage there to be between 6 and 7cm of healthy bone remaining.I would like to have an implant with a short stubby/ broad stem, with sideplates and cross screws to be available if possible.If the purchase is not good in the remaining segment, i will have to convert to a total femur replacement.".

Event Description

A patient specific implant request form was received for the patient's left diaphyseal femur.Noted on the form: "currently has a custom stanmore implant.This is loose.Needs to be revised.I would like to retain the proximal segment if possible, and exchange with a new stem.I envisage there to be between 6 and 7cm of healthy bone remaining.I would like to have an implant with a short stubby/ broad stem, with sideplates and cross screws to be available if possible.If the purchase is not good in the remaining segment, i will have to convert to a total femur replacement.".

Manufacturer Narrative

Reported event: an event regarding loosening involving a patient specific, midshaft femoral replacement, 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: the implant in situ was for proximal femoral replacement which was a revision from previous diaphyseal femoral implant.The surgeon reported loosening of the stem.The ct image provided shows massive radiolucent lines along the femoral stem mainly between the cement mantle and bone, but also between the stem and cement mantle.The femoral bone has undergone significant bone resorption and remodelling, left a very thin cortex.Therefore, the radiographic review can confirm the clinical report and reason for revision.Device history review: review of the product history records indicate the device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.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: FEMORAL DIAPHYSEAL REPLACEMENT - DISTAL 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; UK WD6 3SJ
• Manufacturer (Section G): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; UK WD6 3SJ
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 16377354
• MDR Text Key: 309552613
• Report Number: 3004105610-2023-00017
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/30/2023

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 21142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2023
• Initial Date FDA Received: 02/15/2023
• Supplement Dates Manufacturer Received: 03/22/2023
• Supplement Dates FDA Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 17 YR
• Patient Sex: Male