MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® TL CLASSIC STEM SIZE 7 STRAIGHT SHORT NE; HIP COMPONENT

Model Number	PRTLS027
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, on (b)(6) 2021, the patient underwent right total hip arthroplasty, synovectomy, hip joint release, and acetabular base autogenous bone grafting in the hospital.The patient recovered and was discharged from hospital.On (b)(6) 2022 (7 months after operation), the patient had pain in his right thigh for half a year and went to the hospital for examination.On (b)(6) 2022, the doctor diagnosed the patient as postoperative implant loosening.During this time, the doctor made a thorough examination of the patient.On (b)(6) 2022, the doctor performed the revision of the right total artificial hip in the operating room.The pain disappeared after operation, and the patient recovered and was discharged from hospital.

• Brand Name: PROFEMUR® TL CLASSIC STEM SIZE 7 STRAIGHT SHORT NE
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 14277906
• Report Number: 3010536692-2022-00151
• Device Sequence Number: 11885497
• Product Code: JDI
• UDI-Device Identifier: M684PRTLS0271
• UDI-Public: M684PRTLS0271
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K123688
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 05/03/2022

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: Health Professional
• Device Model Number: PRTLS027
• Device Catalogue Number: PRTLS027
• Device Lot Number: N/I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/14/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 05/04/2022
• 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 Sex: Male