MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® MODULAR FEMORAL NECK; HIP COMPONENT

Model Number	PHA01242
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient complained of pain and visited the clinic on aug 6th.The x-ray image suggested a dislocation and disassociation.Due to dislocation/disassociation, revision tha was performed.Stem was not revised.The neck, head and cup were revised.Tha is carried out with other companies g7 cups.(b)(4).Physician's findings; ''the x-ray seemed to have clearly turned out, but since it had returned to its original state, it was said that it was not necessary this time to propose an actual product survey.''.

• Brand Name: PROFEMUR® MODULAR FEMORAL NECK
• 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: 12451121
• Report Number: 3010536692-2021-00516
• Device Sequence Number: 14317166
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012421
• UDI-Public: M684PHA012421
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2021

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: PHA01242
• Device Catalogue Number: PHA01242
• Device Lot Number: 1754043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 12/31/2021
• 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: 73 YR
• Patient Sex: Female