MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® TL CLASSIC STEM SIZE 4 VARUS 8 DG LONG N; HIP COMPONENT

Model Number	PRTLEL24
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/24/2022
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, after confirming the final trial, the stem was driven in, but it floated about 2 mm, so it was driven in hard.Although a suspicious shadow was confirmed by postoperative x-ray, it was decided to follow up the patient.The next day, we suspected mobility and confirmed it with x-rays and ct.A fracture was found.In addition, he developed hypertensive encephalopathy and cardiac disease, and his dementia is difficult to control.It was determined that reoperation was not possible.He is now wearing a protective hip brace and will be loaded in at least 8 weeks.The patient does not complain of pain, but we believe it is due to dementia.(b)(4).

• Brand Name: PROFEMUR® TL CLASSIC STEM SIZE 4 VARUS 8 DG LONG N
• 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: 14024553
• Report Number: 3010536692-2022-00105
• Device Sequence Number: 2595768
• Product Code: JDI
• UDI-Device Identifier: M684PRTLEL241
• UDI-Public: M684PRTLEL241
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 07/06/2022

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: Other
• Device Model Number: PRTLEL24
• Device Catalogue Number: PRTLEL24
• Device Lot Number: 16880211794872
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/15/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 07/06/2022
• 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 Age: 86 YR
• Patient Sex: Female