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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE PROXIMAL TIBIA LIMB SALVAGE SYSTEM

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STANMORE IMPLANTS WORLDWIDE PROXIMAL TIBIA LIMB SALVAGE SYSTEM Back to Search Results
Catalog Number UNK_STM
Device Problem Break (1069)
Patient Problem Injury (2348)
Event Date 01/04/2018
Event Type  Injury  
Manufacturer Narrative
An event regarding an alleged broken and warped hinge involving a custom proximal tibia was reported. The event was confirmed. Method and results product evaluation and results: not performed as no items were returned. Medical records received and evaluation: x-ray review- based on a review of the provided information, the reported fracture of the hinge has been confirmed. The reported fracture could be as a result of patient factors such as overweight or activity levels, not necessarily related to the design and manufacture of the device itself. Product history review: review of the device history record indicate one device was manufactured and accepted into final stock on 31 oct 1989, with no reported discrepancies. Complaint history review: based on the device identification the complaint databases were reviewed from 2012 to present for similar reported events regarding tibial hinge crack/fracture. There have been 3 other events. Conclusions: it is reported that during a procedure to rebush a custom proximal tibia, that had been implanted for 28 years, it was noted that the hinge was broken and warped. The exact cause of the event could not be determined because further information such as device return, 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 no devices and insufficient information was received by siw. If devices and additional information become available to indicate further evaluation is warranted, this record will be re-opened. Siw will continue to monitor for trends. Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product nonconformity or unanticipated hazard. Please note: the reported device is similar to a patient specific proximal tibia device approved for compassionate use in the united states. Device not returned.
 
Event Description
A new prescription form has been received for a revision due to a broken hinge. It has been further reported that the patient underwent a rebushing procedure on (b)(6) 2017. During the revision procedure on (b)(6) 2017, the revision components supplied (pin 21175) could not be used as the tibial component (from pin 1519 in situ for 28 years) had warped meaning the new axle could not align. A new revision implant was requested.
 
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Brand NamePROXIMAL TIBIA
Type of DeviceLIMB SALVAGE SYSTEM
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
margaret foley
210 centennial avenue
centennial park, elstree
borehamwood WD6 3-SJ
GB   WD6 3SJ
2082386500
MDR Report Key8079027
MDR Text Key127535325
Report Number3004105610-2018-00136
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeGB
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 11/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/1990
Device Catalogue NumberUNK_STM
Device Lot NumberPIN 1519
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 Received01/04/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/1989
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: 11/16/2018 Patient Sequence Number: 1
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