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

Model Number	PRGLCLS6
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530); Swelling/ Edema (4577)
Date of Event	04/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, the patient experienced dislocation, loss of mobility, swelling, adverse tissue reaction, and pain due to metal-on-metal components.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Additional 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
• Common Device Name: 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
• Report Number: 3010536692-2023-00018
• Device Sequence Number: 6701375
• Product Code: JDL
• UDI-Device Identifier: M684PRGLCLS61
• UDI-Public: M684PRGLCLS61
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2023

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2023
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 02/21/2023
• 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: Male