MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® GLADIATOR® CLASSIC PLASMA SIZE 6 STRAIGH; HIP COMPONENT

Model Number PRGLCLS6

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 04/27/2021

Event Type  Injury  

Event Description

Allegedly, the patient experienced dislocation, loss of mobility, swelling, adverse tissue reaction, and pain due to metal-on-metal components.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information received on 02/09/2023, the incident is not related to a device failure.Please void this report.

• Brand Name: PROFEMUR® GLADIATOR® CLASSIC PLASMA SIZE 6 STRAIGH
• 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: 16283186
• MDR Text Key: 308624247
• Report Number: 3010536692-2023-00018
• Device Sequence Number: 1
• Product Code: JDL
• UDI-Device Identifier: M684PRGLCLS61
• UDI-Public: M684PRGLCLS61
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K110399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PRGLCLS6
• Device Catalogue Number: PRGLCLS6
• Device Lot Number: 1720523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2023
• 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
• Patient Sex: Male