MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN SOLAR ELBOW HUMERAL COMPONENT; PROSTHESIS, ELBOW, HEMI-, HUMERAL, METAL

Catalog Number UNK_JR

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 01/12/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

This pi is for the revision of the patient's right elbow in 2015.In following up on a product inquiry regarding an impending revision of patient's right elbow, rep confirmed that a revision in 2015 was also of a solar elbow.Reason for revision is unknown at the time of this report.

Manufacturer Narrative

An event regarding revision involving an unknown solar humeral component was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical information by a clinical consultant indicated: "this patient underwent a primary solar total elbow prosthesis which failed and subsequently underwent a revision also with a solar total elbow prosthesis.This revision implant also failed and another revision is contemplated.The root cause of failure of this second revision implant cannot be determined with certainty.Nor can the cause of the primary surgery and the first revision surgery be determined.There is not enough information provided.I can confirm that the implant placed in 2015 has failed due to loosening, osteolysis and disassociation from the bone.The root cause of this type of failure is multifactorial including surgical technique factors, patient factors such as activity level, bmi, and host bone integrity and strength.At this point it does not appear that any causality of the failure is due to the implant itself.Given the obvious radiolucencies and osteolysis of the humerus i believe it would wise to replace it rather than mating it with a new ulnar component." product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised for an unknown reason.The medical records provided also did not indicate the reason for revision.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, relevant pre- and post-operative x-rays and the revision 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.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

This pi is for the revision of the patient's right elbow in 2015.In following up on a product inquiry regarding an impending revision of patient's right elbow, rep confirmed that a revision in 2015 was also of a solar elbow.Reason for revision is unknown at the time of this report.

• Brand Name: UNKNOWN SOLAR ELBOW HUMERAL COMPONENT
• Type of Device: PROSTHESIS, ELBOW, HEMI-, HUMERAL, METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15704206
• MDR Text Key: 302764675
• Report Number: 0002249697-2022-01574
• Device Sequence Number: 1
• Product Code: KWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 76 YR
• Patient Sex: Male