MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® PRESERVE CLASSIC SIZE 4 STRAIGHT HIP STE; HIP COMPONENT

Model Number	PPRCLS04
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, continued pain in left hip.Prosthesis in good position 3-weeks post-op, with subsidence of stem noted at 3-months post-op.No fracture or signs of infection.No change to implant position at 6-months.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• Brand Name: PROFEMUR® PRESERVE CLASSIC SIZE 4 STRAIGHT HIP STE
• 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: 19201004
• Report Number: 3010536692-2024-00274
• Device Sequence Number: 8106765
• Product Code: LZO
• UDI-Device Identifier: M684PPRCLS041
• UDI-Public: M684PPRCLS041
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 09/20/2024

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: PPRCLS04
• Device Catalogue Number: PPRCLS04
• Device Lot Number: 1846022
• 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: 04/01/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 09/20/2024
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 95 KG