MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE FEM KNEE W/EPI L STD; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number MKFE-LSTD

Device Problems Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Inadequate Osseointegration (2646)

Event Date 11/16/2021

Event Type  Injury  

Event Description

It has been reported the patient requires a revision.Clinical summary: " (b)(6) year old patient, operated in 2012 for distal femoral resection with reconstruction by rotatory hinge prosthesis, in the context of osteosarcoma.This was a stanmore prosthesis with a tibial reconstruction implant.At the femoral level, it is a distal femoral implant with a 2cm spacer.The patient presented with femoral pain and imaging revealed a loosening of the femoral bone without any evidence of an infectious problem.No tibial loosening.Revision decision to change the femoral implant".

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

It has been reported the patient requires a revision - clinical summary: "24 year old patient, operated in 2012 for distal femoral resection with reconstruction by rotatory hinge prosthesis, in the context of osteosarcoma.This was a stanmore prosthesis with a tibial reconstruction implant.At the femoral level, it is a distal femoral implant with a 2cm spacer.The patient presented with femoral pain and imaging revealed a loosening of the femoral bone without any evidence of an infectious problem.No tibial loosening.Revision decision to change the femoral implant".Update : clinical consultant reviewed the imaging provided and stated the following " [.] the ct image provided shows remarkable radiolucent line between the cement mantle and bone.There was bone remodelling near the bone resection and tip of the stem.Therefore, the radiographic review can confirm the clinical report and reason for revision".

Manufacturer Narrative

Reported event: an event regarding loosening involving a mets, distal femoral replacement, femoral component was reported.A clinical consultant reviewed the imaging provided and confirmed the loosening of the femoral stem only, stating the following: "[.] the ct image provided shows remarkable radiolucent line between the cement mantle and bone.There was bone remodelling near the bone resection and tip of the stem.Therefore, the radiographic review can confirm the clinical report and reason for revision".Based on the information provided there is no indication or allegation that the femoral component reported in this investigation may have contributed to the event.A full investigation has been completed for the femoral stem under mfr report ref # 3004105610-2022-00013, therefore this mdr is being cancelled.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: FEM KNEE W/EPI L STD
• 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: 13176237
• MDR Text Key: 283307851
• Report Number: 3004105610-2022-00001
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/02/2022

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: MKFE-LSTD
• Device Lot Number: A26653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 01/06/2022
• Supplement Dates Manufacturer Received: 02/28/2022
• Supplement Dates FDA Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2020
• 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: 26 YR
• Patient Sex: Male
• Patient Weight: 125 KG