MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH LG, RT LONG STEM HUMERAL ASSEMBLY; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Model Number	5005-013R
Medical Device Problem Codes	Degraded (1153); Migration (4003)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	10/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Current ulna implant has eroded through the bone cause failure and little to no range of motion for the patient.
Additional Manufacturer Narrative
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.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.
Additional Manufacturer Narrative
An event regarding osteolysis involving a solar humeral was reported.The event was confirmed via clinician review of the provided medical records.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: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient will be revised due to loosening of the ulna component and osteolysis surrounding the humeral component.The event was confirmed by clinician review of the provided medical records.A root cause could not be determined from the information provided.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 or Problem Description
Current ulna implant has eroded through the bone cause failure and little to no range of motion for the patient.

• Brand Name: LG, RT LONG STEM HUMERAL ASSEMBLY
• Common Device Name: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15812792
• Report Number: 0002249697-2022-01653
• Device Sequence Number: 15210656
• Product Code: JDC
• UDI-Device Identifier: 07613327137705
• UDI-Public: 07613327137705
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K980502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: 5005-013R
• Device Catalogue Number: 5005-013R
• Device Lot Number: MLN43A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2022
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White