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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE PROXIMAL TIBIA - FEMORAL COMPONENT PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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STANMORE IMPLANTS WORLDWIDE PROXIMAL TIBIA - FEMORAL COMPONENT PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number UNK_STM
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bone Fracture(s) (1870)
Event Date 09/07/2020
Event Type  Injury  
Manufacturer Narrative
The reported device is similar to a device approved for compassionate use in the united states. Reported event: an event regarding periprosthetic fracture involving a patient specific, proximal tibia, was reported. The event was confirmed by x ray review. Method & results: device evaluation and results: not performed as product was not returned clinician review: a review of the provided medical records and/or x-rays by a clinical consultant indicated: the implant in situ was for proximal tibial replacement which was inserted on 17apr2008. The surgeon reported infection and septic loosening of the implant. The x-rays provided show that the original implant has been removed and femoral and tibial metal nails were in place. There is periprosthetic fracture on the medial side mid-shaft of the femur, but rest of the femoral bone is in good condition. The posterior side of the tibial bone has some defects near the resection otherwise the rest of the bone is in good condition. No sign of the infection can be observed through the radiographic images and the septic loosening of the implant cannot be confirmed due to removal of the implant. Device history review: review of the product history records indicate 1 devices were manufactured and accepted into final stock on the 14mar2008 with no reported discrepancies. Complaint history review: there have been no other relevant events. 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, x-rays 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.
 
Event Description
Reason for revision: infected epr prox tibia, post first stage, septic loosening. Update (b)(6) 2020: x-ray review : " the x-rays provided show that the original implant has been removed and femoral and tibial metal nails were in place. There is periprosthetic fracture on the medial side mid-shaft of the femur, but the rest of the femoral bone is in good condition".
 
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Brand NamePROXIMAL TIBIA - FEMORAL COMPONENT
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 Key11001581
MDR Text Key221215695
Report Number3004105610-2020-00192
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUK
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 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2008
Device Catalogue NumberUNK_STM
Device Lot NumberPIN 13699
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 Received11/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/14/2008
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: 12/14/2020 Patient Sequence Number: 1
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