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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE BUSHINGS - TOTAL ELBOW PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

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STANMORE IMPLANTS WORLDWIDE BUSHINGS - TOTAL ELBOW PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED Back to Search Results
Catalog Number UNK_STM
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Injury (2348)
Event Date 05/22/2020
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. Device not returned.
 
Event Description
A patient specific prescription form was received for patient's total elbow with reason for revision noted: "dislocation of bushings/axle if the model has it in total elbow replacement (megaprosthesis). Failure of bushings. ".
 
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Brand NameBUSHINGS - TOTAL ELBOW
Type of DevicePROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
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
diana rogers
210 centennial avenue
centennial park, elstree
borehamwood WD6 3-SJ
GB   WD6 3SJ
2082386500
MDR Report Key10159934
MDR Text Key195317241
Report Number3004105610-2020-00110
Device Sequence Number1
Product Code JDC
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 06/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_STM
Device Lot NumberPIN 22365
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 Received05/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/09/2020
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: 06/16/2020 Patient Sequence Number: 1
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