MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR GLADIATOR DISTAL CENTRALIZER SZ 4; HIP COMPONENT

Model Number	PRGLDC04
Medical Device Problem Codes	Use of Device Problem (1670); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was squatting which lead out a luxation of the implanted hip; later it could be repositioned by closed reposition.

• Brand Name: PROFEMUR GLADIATOR DISTAL CENTRALIZER SZ 4
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10499554
• Report Number: 3010536692-2020-00604
• Device Sequence Number: 11555370
• Product Code: JDI
• UDI-Device Identifier: M684PRGLDC041
• UDI-Public: M684PRGLDC041
• Combination Product (Y/N): N
• Initial Reporter Country: DE
• PMA/510(K) Number: K111910
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/07/2020

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: Health Professional
• Device Model Number: PRGLDC04
• Device Catalogue Number: PRGLDC04
• Device Lot Number: 1724232
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/25/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 09/07/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Weight: 78