MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. GLADIATOR® BIPOLAR 41MM OD X 22MM ID; HIP COMPONENT

Model Number GLBP2241

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Allegedly, revised/replaced neck and did a total hip due to shell was disassociated.Device that we cannot confirm if it was revised: product id: pha00610, stem revision "profemur® z" size 5, lot: 088479044, qty: 1.

Manufacturer Narrative

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

• Brand Name: GLADIATOR® BIPOLAR 41MM OD X 22MM ID
• 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: 15319711
• MDR Text Key: 298875185
• Report Number: 3010536692-2022-00304
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: M684GLBP22411
• UDI-Public: M684GLBP22411
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062693
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: GLBP2241
• Device Catalogue Number: GLBP2241
• Device Lot Number: 0501066495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/09/2022
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1