MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR NECK VAR/VAL 8DG SHORT COBALT CHROME; HIP COMPONENT

Model Number	PHAC1252
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	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 or about (b)(6) 2020 it was discovered that the device failed due to metal debris, corrosion and resultant metal ions, due to the metal on metal design between the articulating surfaces.This patient had metal and polyethylene articulating components.
Additional Manufacturer Narrative
Updated incident description.
Event or Problem Description
Allegedly, on or about (b)(6) 2020 it was discovered that the device failed due to metal debris, corrosion and resultant metal ions, due to the metal on metal design between the articulating surfaces.This patient had metal on polyethylene articulating components.It is also alleged that the femoral stem was loose and had areas of corrosion between the modular neck and femoral stem.

• Brand Name: PROFEMUR NECK VAR/VAL 8DG SHORT COBALT CHROME
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11585443
• Report Number: 3010536692-2021-00176
• Device Sequence Number: 4846430
• Product Code: JDI
• UDI-Device Identifier: M684PHAC12521
• UDI-Public: M684PHAC12521
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2021

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: PHAC1252
• Device Catalogue Number: PHAC1252
• Device Lot Number: 1001171366
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/09/2021
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 06/07/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention