MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. LINEAGE® DURAMER® ACETABULAR LINER 28MM 15° STD GR; HIP COMPONENT

Model Number	36452801
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/01/2024
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 doctor reports that the patient has evidence of early polyethylene wear; he has not yet scheduled removal of the material.Related mpo products: product id: 36430046 lineage® acetabular shell 46mm quad hemi flare std group 1/ lot no.: 16453831657950/ qty: 1 product id: 26012802 cocr femoral head 28mm slt taper +0mm neck/ lot no.: 1694225/ qty: 1 product id: 18080301 cancellous 6.5mm self-tapping bone screw 2.0cm length/ lot no.: 1718278/ qty: 1 product id: 18080301 cancellous 6.5mm self-tapping bone screw 2.0cm length/ lot no.: 1711513/ qty: 1 product id: pha0cls3 profemur® z classic stem sz 3 straight short neck/ lot no.: 1737747/ qty: 1.

• Brand Name: LINEAGE® DURAMER® ACETABULAR LINER 28MM 15° STD GR
• 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: 21978197
• Report Number: 3010536692-2025-00265
• Device Sequence Number: 18454700
• Product Code: LPH
• UDI-Device Identifier: M684364528011
• UDI-Public: M684364528011
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K002149
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 06/24/2025

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: 36452801
• Device Catalogue Number: 36452801
• Device Lot Number: 4351735
• 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: 04/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female