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

Model Number PHA01202

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Metal Related Pathology (4530)

Event Type  Injury  

Event 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.

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Manufacturer Narrative

Section h.6: medical device problem code updated.

• Brand Name: PROFEMUR® MODULAR FEMORAL NECK
• Type of Device: 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
• MDR Text Key: 303219890
• Report Number: 3010536692-2022-00402
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012021
• UDI-Public: M684PHA012021
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 10/24/2022
• Initial Date FDA Received: 11/07/2022
• Supplement Dates Manufacturer Received: 10/24/2022
• Supplement Dates FDA Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention