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

Model Number	PHA00262
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	Insufficient Information (4580)
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 presented with progressive left hip pain, elevated ion levels, osteolysis about the components, adverse local tissue reaction, and lack of mobility, plaintiff's revision surgery was necessary because the device failed due to corrosion at the neck-stem junction of the device.The legal file mentions a revision surgery on (b)(6) 2022.Since we do not have enough information about this revision all the related components are going to be captured in the (b)(6) 2022 surgery.

• Brand Name: PROFEMUR® Z STEM PLASMA SPRAYED
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 19560104
• Report Number: 3010536692-2024-00350
• Device Sequence Number: 6806443
• Product Code: LPH
• UDI-Device Identifier: M684PHA002621
• UDI-Public: M684PHA002621
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

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: PHA00262
• Device Catalogue Number: PHA00262
• Device Lot Number: 1652270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 11/15/2024
• 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: Female