MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. LINEAGE® ACETABULAR SHELL 52MM QUAD HEMI FLARE STD; HIP COMPONENT

Model Number	36430052
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, the patient underwent thr in 2009.Revised on (b)(6) 2025 due to a peri-prosthetic fracture sustained after a fall.Mpo's femoral components revised with another manufacturer's long stem and head.(b)(4).
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• Brand Name: LINEAGE® ACETABULAR SHELL 52MM QUAD HEMI FLARE STD
• 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: 22062175
• Report Number: 3010536692-2025-00270
• Device Sequence Number: 7812556
• Product Code: LPH
• UDI-Device Identifier: M684364300521
• UDI-Public: M684364300521
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K002149
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

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: 36430052
• Device Catalogue Number: 36430052
• Device Lot Number: 028794004
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 12/24/2025
• 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: Female