MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® Z CLASSIC STEM SIZE 8 STRAIGHT LONG NECK; HIP COMPONENT

Model Number	PHA0S246
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
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
Information from clinical study # (b)(6): patient # (b)(6) reported the following adverse events: pain and functional impairment.This adverse event did not end up in revision surgery.
Additional Manufacturer Narrative
The alleged complaint could not be confirmed.Mpo was made aware of this incident through a clinical study performed using mpo implants.This incident occurred in march of 2017.It was reported that no revision surgery was required.These implants were not returned for investigation, nor were any pictures provided to assist with the investigation.Medical data was provided; however, the data did not contain the lot numbers for the implants.It is unknown when these implants were manufactured, or if they were manufactured to specification due to the unknown lot number.There are no trends for these implants and failures, however, there has been an increase in complaints involving profemur® z classic femoral stems.A review of these complaints reveal that they have all been reported due to this clinical study.It cannot be concluded what the level of contribution, if any, that the product had to the complaint.No further evaluations can be made without return of the product or receipt of other clinical information.The mpo hip systems package insert (150803-9) lists inadequate range of motion due to improper selection or positioning of components, by femoral impingement, and periarticular calcification; and pain as a potential adverse effects of total hip arthroplasty.Additionally, it also states periodic, long-term follow-up is recommended to monitor the position and state of the prosthetic components, as well as the condition of the adjoining bone.Periodic post-operative x-rays are recommended for close comparison with early post-op conditions to detect long term evidence of changes in position, loosening, bending, or cracking of components.Mpo will continue to monitor this issue through complaint tracking.The device history record (dhr) for this product was unable to be reviewed.This failure mode is listed in the current package insert and risk documentation for this device.There were no trends identified per mpo trending procedures.This issue will continue to be monitored through complaint tracking.

• Brand Name: PROFEMUR® Z CLASSIC STEM SIZE 8 STRAIGHT LONG NECK
• 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: 21324259
• Report Number: 3010536692-2025-00038
• Device Sequence Number: 15576933
• Product Code: JDL
• UDI-Device Identifier: M684PHA0S2461
• UDI-Public: M684PHA0S2461
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K021346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 12/05/2025

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: PHA0S246
• Device Catalogue Number: PHA0S246
• 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: 01/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown