MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® Z STEM; HIP COMPONENT

Model Number	PHA00240
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, device implanted in left side failed due to corrosion at the neck-stem junction, creating pain and physical impairment.All products revised.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• Brand Name: PROFEMUR® Z STEM
• 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: 14674918
• Report Number: 3010536692-2022-00215
• Device Sequence Number: 4635950
• Product Code: LPH
• UDI-Device Identifier: M684PHA002401
• UDI-Public: M684PHA002401
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2021
• 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): 08/08/2022

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: PHA00240
• Device Catalogue Number: PHA00240
• Device Lot Number: 0611373370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/25/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 08/08/2022
• 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: Male