MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE UNKNOWN TOTAL ELBOW REPLACEMENT - AXLE; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

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.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; 3004105610-2020-00109).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.".

Manufacturer Narrative

Update 16 april 2021 - upon further investigation, the unknown axle component was supplied combined with the ulna component pin 2744 so will be investigated and reported under 3004105610-2021-00019, therefore this mdr is being cancelled.

Event Description

As reported: "has a patient with a custom distal humeral replacement which has dislocated again.(fda references (b)(4)).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." update 16 april 2021 - upon further investigation, the unknown axle component was supplied combined with the ulna component pin 2744 so will be investigated and reported under 3004105610-2021-00019, therefore this mdr is being cancelled.

• Brand Name: UNKNOWN TOTAL ELBOW REPLACEMENT - AXLE
• 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: 11264632
• MDR Text Key: 229816053
• Report Number: 3004105610-2021-00018
• 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: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR