MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® TL STEM SZ 4; HIP COMPONENT

Model Number	PRTL0024
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/29/2023
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, patient who underwent superpath prosthesis on (b)(6) dislocated on (b)(6) and stem and changeable neck were dislocated during manual healing, and revision was performed on (b)(6) in an open surgery.Physician's findings: whether there are previous reports of stem and changeable neck disassembly.Product problem noted.Caused burden to the patient.Request to determine the cause of the problem.The above requests have been received.Reporting party's findings and status of response: it is not usual for the stem and changeable neck to come off by manual manipulation.(b)(4).

• Brand Name: PROFEMUR® TL STEM SZ 4
• 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: 17806745
• Report Number: 3010536692-2023-00170
• Device Sequence Number: 7249757
• Product Code: JDI
• UDI-Device Identifier: M684PRTL00241
• UDI-Public: M684PRTL00241
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted 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): 10/20/2023

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: PRTL0024
• Device Catalogue Number: PRTL0024
• Device Lot Number: 1950541
• 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: 08/30/2023
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 10/20/2023
• 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: 88 YR
• Patient Sex: Female
• Patient Weight: 43 KG