MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE DISTAL HUMERAL COMPONENT; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Catalog Number UNK_STM

Device Problem Fracture (1260)

Patient Problems Injury (2348); 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.An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.

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.".

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 28 sep 2020: x ray review confirmed " the axle for elbow joint has backed out.".

Manufacturer Narrative

Reported event: an event regarding crack/ fracture involving a patient specific, distal humerus, humeral component was reported.The event was confirmed by x-ray review.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 14 feb 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.

• Brand Name: DISTAL HUMERAL COMPONENT
• Type of Device: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
• Manufacturer (Section D): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; UK WD6 3SJ
• MDR Report Key: 10360336
• MDR Text Key: 201514265
• Report Number: 3004105610-2020-00129
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 16143
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/08/2020
• Initial Date FDA Received: 08/03/2020
• Supplement Dates Manufacturer Received: 10/08/2020
• Supplement Dates FDA Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR