MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® LX STEM SZ 13 5/8 PS COATED; HIP COMPONENT

Model Number	PRLX5813
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient underwent revision surgery on right hip due to pain, a subsequent mri which revealed significant metallosis as well as pseudotumor founded, the capsule and short external rotators were not attached to the posterior trochanter, there was a significant metallosis of the trunnion of the dual modular neck as well as the inner portion of the head and at the junction of the neck and stem on both sided of the taper.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• Brand Name: PROFEMUR® LX STEM SZ 13 5/8 PS COATED
• 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: 20362012
• Report Number: 3010536692-2024-00455
• Device Sequence Number: 8004358
• Product Code: KWA
• UDI-Device Identifier: M684PRLX58131
• UDI-Public: M684PRLX58131
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K081090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2023
• 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: PRLX5813
• Device Catalogue Number: PRLX5813
• Device Lot Number: 0901197346
• 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: 09/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 07/07/2025
• 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 Age: 68 YR
• Patient Sex: Male