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

Model Number	PHA01202
Health Effect - Clinical Code	Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to peri-prosthetic fracture ? stem|dislocation/subluxation.Revision njr number: (b)(4).Side:r.Primary asa: p2 - mild disease not incapacitating.Non-mpo products: part id: 65-6400-50-22 f/m acet shell with ha-tcp calcicoat - 50mm o.D/ lot.Number: 60358559/.Qty:1.Part id: 6415-28-02 alumina insert 48-54 x 28/ lot.Number: 61300387/ qty:1.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Additional Manufacturer Narrative
Section h.6: medical device problem code updated.

• 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: 15743645
• Report Number: 3010536692-2022-00402
• Device Sequence Number: 12546048
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012021
• UDI-Public: M684PHA012021
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• 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,Followup
• Report Date (Section B): 01/04/2023

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: PHA01202
• Device Catalogue Number: PHA01202
• Device Lot Number: 79908909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/24/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2022
• Supplement Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 01/04/2023
• 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 Sex: Unknown