MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR NECK NEUTRAL LONG COBALT CHROME; HIP COMPONENT

Model Number	PHAC1204
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, the patient was revised as a result of pain, elevated cobalt and chromium levels, and a large pseudotumor due to the failed metal-metal junction corrosion at the cocr modular neck and the titanium stem.Excluding the issues concerning corrosion of the modular neck, the patient's hip replacement was not otherwise in need of a hip revision surgery.

• Brand Name: PROFEMUR NECK NEUTRAL LONG COBALT CHROME
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11243402
• Report Number: 3010536692-2021-00045
• Device Sequence Number: 11742373
• Product Code: JDL
• UDI-Device Identifier: M684PHAC12041
• UDI-Public: M684PHAC12041
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K091423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2021

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: PHAC1204
• Device Catalogue Number: PHAC1204
• Device Lot Number: 1416971
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/06/2021
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 03/05/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention