MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® L HIP STEM SIZE 3; HIP COMPONENT

Model Number PHA05506

Device Problem Loss of Osseointegration (2408)

Patient Problem Osteolysis (2377)

Event Type  Injury  

Event Description

Allegedly, patient was revised due to loosening - stem|loosening - socket|lysis - stem|unexplained pain|adverse soft tissue reaction to particulate debris.Revision njr number: (b)(4).Side:l.Primary asa: p1 - fit and healthy.

• Brand Name: PROFEMUR® L HIP STEM SIZE 3
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 18955440
• MDR Text Key: 338304139
• Report Number: 3010536692-2024-00139
• Device Sequence Number: 1
• Product Code: LPH
• 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
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PHA05506
• Device Catalogue Number: PHA05506
• Device Lot Number: 048563973
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention