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U.S. Department of Health and Human Services

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

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STANMORE IMPLANTS WORLDWIDE COL OVAL Ø=30X33MM S/COLLAR HA PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
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".
 
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Brand NameCOL OVAL Ø=30X33MM S/COLLAR HA
Type of DevicePROSTHESIS, 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 Key9626684
MDR Text Key183567024
Report Number3004105610-2020-00015
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K121029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial
Report Date 01/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2021
Device Catalogue NumberMSCOL-O30X33C
Device Lot NumberB15134
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/24/2020 Patient Sequence Number: 1
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