MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® R GRIT BLASTED PROX BODY STD 4 V4; HIP COMPONENT

Model Number	PPW39110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/20/2022
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, breakage of the part and revision surgery done as a consequence.
Additional Manufacturer Narrative
The alleged complaint could not be confirmed.Review of the complaint, ppw00144 lot unk and ppw39110 lot 1621660, does not reveal any evidence of failure involving these implants.Ppw00144 was previously investigated in 2022, but the incident was reopened after new information was received.These implants were not returned for investigation, nor were any pictures or supplemental medical documentation provided to assist in the compliant.This patient was revised approximately 58 months after the primary operation due to alleged fracture of the stem extension component.It is unknown when ppw00144 was manufactured, or if it was manufactured to specification due to the unknown lot number.Ppw39100 was manufactured in 2016.Review of the design history record (dhr) for the subject manufacturing lot indicates that this implant was manufactured to specification.There are no trends for failure with either implant.Despite additional information being provided, no conclusions can be made regarding the level of contribution, if any, that these implants had to the complaint.These stem extensions are typically implanted during complicated use cases, such as revision cases that involve patients with substantial bone loss and/or deformities.Consequently, issues with bone support around the prosthesis may occur and could contribute to implant failure such as loosening and fracture.The current microport hip systems package insert (150803-9) lists "fatigue fracture of the prosthetic component can occur as a result of trauma, strenuous activity, improper alignment, incomplete implant seating, duration of service, loss of fixation, non-union, or excessive weight" as possible adverse effects of total hip arthroplasty.

• Brand Name: PROFEMUR® R GRIT BLASTED PROX BODY STD 4 V4
• 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: 21532245
• Report Number: 3010536692-2025-00071
• Device Sequence Number: 7856970
• Product Code: KWA
• UDI-Device Identifier: M684PPW391101
• UDI-Public: M684PPW391101
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K003016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• 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): 12/04/2025

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: PPW39110
• Device Catalogue Number: PPW39110
• Device Lot Number: 1621660
• 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: 02/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 12/04/2025
• 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: 55 YR
• Patient Sex: Unknown