MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE COL OVAL Ø=30X33MM S/COLLAR HA; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number MSCOL-O30X33C

Device Problem Osseointegration Problem (3003)

Patient Problems Injury (2348); Inadequate Osseointegration (2646)

Event Date 09/13/2019

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding loosening of the femoral collar was confirmed following review of the provided xray images.Method and results: visual inspection - visual inspection indicates that the femoral stem is disassociated from the femoral shaft at the taper lock.The alignment lug of the femoral stem taper lock is broken off and part of the alignment lug remains in the taper lock recess of the femoral shaft.Visual inspection of the femoral stem indicates wear of the taper lock and the distal end of the taper lock.Visual inspection of the collar indicates evidence of biomaterial residue.Visual inspection of the tibial component, axle, bushes and bumper did not identify any damage or non-conformity relevant to the reported event.Clinician review: the implant in situ was for a mets distal femoral replacement, which was inserted on (b)(6) 2019.The surgeon reported loosening of the femoral prosthesis.However, during revision surgery it was confirmed that loosening is not the issue but disassociation between the femoral shaft and femoral component.The x-ray provided showed that rotating hinged component has disassociated with the tibial components and there is a fine radiolucent line at the junction between the resection level and ha collar.The retrieved implant shows that the anti-rotational lug is broken and the femoral shaft has massive wear, which indicated that the femoral principal shaft has disassociated inside the femoral component.Therefore the radiographic assessment can conform the reason for revision.Product history review: review of the product history records indicate 20 devices were manufactured and accepted into final stock on 31mar2016 with no reported discrepancies.Complaint history review: based on the device identification the complaint databases were reviewed for similar events regarding loosening lot b15134 there have been no other events for the lot referenced.Conclusion: an event regarding loosening of the femoral collar was confirmed during xray.The exact cause of the event could not be determined because 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 insufficient information was received by siw.If additional information become available to indicate further evaluation is warranted, this record will be re-opened.

Event Description

The customer reported that : "revision surgery needed : loosening of his right femoral prosthesis, we need to change the prosthetic stem." there is a disassociation between shaft and stem.The xray review confirmed the presence of "a fine radiolucent line at the junction between the resection level and ha collar".

• Brand Name: COL OVAL Ø=30X33MM S/COLLAR HA
• 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
• Manufacturer (Section G): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; GB WD6 3SJ
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; GB WD6 3SJ ; 2082386500
• MDR Report Key: 9626684
• MDR Text Key: 183567024
• Report Number: 3004105610-2020-00015
• 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,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/24/2020

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 Expiration Date: 02/28/2021
• Device Catalogue Number: MSCOL-O30X33C
• Device Lot Number: B15134
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 01/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2016
• 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 Weight: 70