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U.S. Department of Health and Human Services

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

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STANMORE IMPLANTS WORLDWIDE DISTAL HUMERAL COMPONENT PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED Back to Search Results
Catalog Number UNK_STM
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Joint Dislocation (2374)
Event Date 01/12/2021
Event Type  Injury  
Manufacturer Narrative
The reported device is similar to a device approved for compassionate use in the united states. It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies. There have been no other similar events for the lot referenced. Device not returned.
 
Event Description
As reported: "has a patient with a custom distal humeral replacement which has dislocated again. (fda references 3004105610-2020-00110; 3004105610-2020-00108; 3004105610-2020-00109). We provided bushings urgently for this patient last year as we had the components on the shelf, and they¿ve asked if we can provide them urgently again. ".
 
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Brand NameDISTAL HUMERAL COMPONENT
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
diana rogers
210 centennial avenue
centennial park, elstree
borehamwood WD6 3-SJ
UK   WD6 3SJ
2082386500
MDR Report Key11264655
MDR Text Key229808454
Report Number3004105610-2021-00020
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 05/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2012
Device Catalogue NumberUNK_STM
Device Lot NumberPIN 17018
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 Received05/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/30/2012
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: 02/02/2021 Patient Sequence Number: 1
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