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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE DISTAL HUMERAL REPLACEMENT - AXLE PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

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STANMORE IMPLANTS WORLDWIDE DISTAL HUMERAL REPLACEMENT - AXLE PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED Back to Search Results
Catalog Number UNK_STM
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Insufficient Information (4580)
Event Date 07/08/2020
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 "backing out" involving a patient specific, distal humeral, axle 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 x-rays by a clinical consultant indicated: the implant in situ was for a distal humeral replacement which was inserted in 2013. The surgeon reported a fracture of the humeral component. The x-ray provided showed that distal humeral component has fractured and the axle for elbow joint has backed out. Therefore, the radiographic review confirms the reason of revision. Device history review: review of the product history records indicate 1 devices were manufactured and accepted into final stock on the (b)(6) 2013 with no reported discrepancies. Complaint history review: there have been no other 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, 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
A patient specific prescription form was received for patient's left distal humeral component with reason for revision noted: "revision of distal component of subtotal distal humeral epr due to fracture of condyle at elbow hinge. " update (b)(6) 2020: x ray review confirmed " the axle for elbow joint has backed out. ".
 
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Brand NameDISTAL HUMERAL REPLACEMENT - AXLE
Type of DevicePROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
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
daniela davila
2555 davie road
centennial park, elstree
fort lauderdale, FL 33317
9546280700
MDR Report Key10716917
MDR Text Key212458621
Report Number3004105610-2020-00170
Device Sequence Number1
Product Code JDC
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,Followup
Report Date 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_STM
Device Lot NumberPIN 16143
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 Received11/26/2020
Was Device Evaluated by Manufacturer? No
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: 10/22/2020 Patient Sequence Number: 1
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