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

Catalog Number UNK_STM

Device Problem Loss of Osseointegration (2408)

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

Event Date 08/16/2021

Event Type  Injury  

Manufacturer Narrative

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.Device not returned.

Event Description

The customer reported to the sales rep "we have this young guy of (b)(6) yo.No past medical history.He had an conventional osteosarcoma of the distal left femur 2 years ago treated with chemotherapy, surgical resection with clear margins, good response to chemotherapy and then adjuvant chemotherapy.Reconstruction was performed with a cemented modular distal femur stanmore prosthesis, full polyethylene rotative hinge.He has an aseptic loosening of the femoral part with a big bone loss, and a short remaining femur.He will have a pet ct to make sure he has no local recurrence of course.Chest ct is clear".Update 18/august/2021 wg: a patient specific implant request form was received for the patient's left mets distal femur.Noted on the form: "aseptic loosening of the femoral part of a left distal femur pe rotative hinge prosthesis.".

Event Description

The customer reported to the sales rep "we have this young guy of 15 yo.No past medical history.He had an conventional osteosarcoma of the distal left femur 2 years ago treated with chemotherapy, surgical resection with clear margins, good response to chemotherapy and then adjuvant chemotherapy.Reconstruction was performed with a cemented modular distal femur stanmore prosthesis, full polyethylene rotative hinge.He has an aseptic loosening of the femoral part with a big bone loss, and a short remaining femur.He will have a pet ct to make sure he has no local recurrence of course.Chest ct is clear".Update 18/august/2021 wg: a patient specific implant request form was received for the patient's left mets distal femur.Noted on the form: "aseptic loosening of the femoral part of a left distal femur pe rotative hinge prosthesis.".

Manufacturer Narrative

Reported event: an event regarding loosening involving a mets, distal femur replacement, femoral stem was reported.The event was confirmed.Method & results: device evaluation and results: not performed as product was not returned.A review of the provided x-rays by a clinical consultant indicated: clinical review: the implant in situ was for a mets distal femoral replacement which was inserted in 2019.The surgeon reported aseptic loosening of the femoral stem.The ct image provided shows that there is massive radiolucent line along the stem and significant bone resorption and remodelling, especially near the ha collar.The remaining cortical bone is very thin, and the proximal femoral bone is tilted in varus.Therefore, the radiographic review can confirm the clinical report of femoral stem loosening and reason for revision.Device history review: a review of the product history records could not be performed as the lot / batch information was not provided.Complaint history review: a complaint history review could not be performed as the lot / batch 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: UNKNOWN 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
• 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: 12442388
• MDR Text Key: 270478533
• Report Number: 3004105610-2021-00126
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K121029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 15 YR
• Patient Sex: Male