MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE DISTAL HUMERAL FLEXI-ELBOW BUSHES; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_STM

Device Problems Naturally Worn (2988); Osseointegration Problem (3003)

Patient Problem Inadequate Osseointegration (2646)

Event Date 01/13/2023

Event Type  Injury  

Manufacturer Narrative

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.H3 other text : not available.

Event Description

A patient specific implant request form was received for the patient's right elbow.Noted on the form: "olecranon component is loose.Needs a revision.Will need to change axle and bearings and circlip." proposed revision date is noted as asap.

Event Description

A patient specific implant request form was received for the patient's right elbow.Noted on the form: "olecranon component is loose.Needs a revision.Will need to change axle and bearings and circlip." proposed revision date is noted as asap.

Manufacturer Narrative

Reported event: an event regarding rebushing involving a patient specific, distal humeral replacement, bushing was reported.The event was confirmed by x ray review.Method & results: 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 patient specific distal humeral replacement and the date of insertion is on (b)(6) 2011.The surgeon reported olecranon component is loose.The x-ray images provided showed radiolucent lines along the ulna stem.There were bone lesion and bone resorption of the ulna bone.Therefore, the radiographic review can confirm the clinical report and reason for revision.Device history review: review of the product history records indicate device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.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 FLEXI-ELBOW BUSHES
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• 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, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 16742302
• MDR Text Key: 313304351
• Report Number: 3004105610-2023-00041
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K140898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Catalogue Number: UNK_STM
• Device Lot Number: B7916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 22 YR