MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® NECK A/R VAR/VAL 1 LONG COBALT CHROME; HIP COMPONENT

Model Number	PHAC1224
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, on (b)(6) 2015, patient had a right total hip arthroplasty.Patient received a profemur® long cobalt chrome modular neck (phac1224) and a profemur® z femoral stem made of titanium alloy.On (b)(6) 2020 due to the failure of the device, patient's device was surgically removed by jakub tatka, m.D., at new york presbyterian lawrence hospital in bronxville, ny in a surgical procedure commonly called a "revision." during her revision surgery, dr.Tatka noted "metallosis and corrosion changes on the taper of the neck and body of the stem taper" and excised metallosis and a pseudotumor.Due to the failure of her profemur® total hip system, dr.Tatka needed to remove the well-fixed femoral stem.Patient has also sustained pain.The cup and liner have not been indicated in the report to be microport products.The cup, liner and head have not been indicated as revised components.

• Brand Name: PROFEMUR® NECK A/R VAR/VAL 1 LONG COBALT CHROME
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 14621992
• Report Number: 3010536692-2022-00213
• Device Sequence Number: 12041154
• Product Code: JDL
• UDI-Device Identifier: M684PHAC12241
• UDI-Public: M684PHAC12241
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K091423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2022

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: Other
• Device Model Number: PHAC1224
• Device Catalogue Number: PHAC1224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/16/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown