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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE FEM STEM CRV 150MM =12>10.5MM PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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STANMORE IMPLANTS WORLDWIDE FEM STEM CRV 150MM =12>10.5MM PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number MSSTM-12X150
Device Problems Material Disintegration (1177); Loss of Osseointegration (2408)
Patient Problems Inadequate Osseointegration (2646); Metal Related Pathology (4530)
Event Date 03/17/2021
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.
 
Event Description
A patient specific prescription form was received for the patient's right distal femur with reason for surgery noted: "spindle cell sarcoma of bone. " and reason for revision noted: "aseptic loosening and metallosis. " during a case review meeting, it was confirmed that loosening and bone resorption is a consequence of the metallosis.
 
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Brand NameFEM STEM CRV 150MM =12>10.5MM
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
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 Key11645203
MDR Text Key254011545
Report Number3004105610-2021-00055
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUK
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,Followup
Report Date 07/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2015
Device Catalogue NumberMSSTM-12X150
Device Lot NumberB7642
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 Received07/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/15/2010
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: 04/09/2021 Patient Sequence Number: 1
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