MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE TOTAL ELBOW BUSHINGS; 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; 3004105610-2020-00108; 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.".

Manufacturer Narrative

Additional manufacturer narrative reported event: an event regarding alleged dislocation involving bushing components in a patient specific ter was reported.The event was not confirmed.Method and results: product evaluation and results: not performed as no items were received.Clinician review: review of the provided x-rays by a clinical consultant indicated: the implant in situ was for distal humeral and proximal ulnar replacement which was inserted on (b)(6) 1993 (ulnar) and (b)(6) 2012 (humeral).The surgeon reported a dislocation of the elbow.The x-ray image provided shows that the elbow joint has disassociated between the humeral and ulnar components.Therefore, the radiographic review can confirm the clinical report and reason for revision.Product history review: review of the product history records indicate the device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there has been 1 other event.Conclusions: the exact cause of the event could not be determined because further information such as pre- and post-operative x-rays and the primary operative report as well as patient history and follow up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and/or insufficient information was received by siw.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be re-opened.The reported device is similar to a device approved for compassionate use in the united states.

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.".

• Brand Name: TOTAL ELBOW BUSHINGS
• 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: 11264630
• MDR Text Key: 229815960
• Report Number: 3004105610-2021-00017
• 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: 05/12/2021

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 Expiration Date: 09/30/2020
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 22365
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR