MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. GLADIATOR® BIPOLAR 50MM OD X 36MM ID; HIP COMPONENT

Model Number GLBP3650

Device Problem No Fail-Safe Mechanism (2990)

Patient Problem Insufficient Information (4580)

Event Date 06/01/2022

Event Type  Injury  

Event Description

Allegedly, patient had 36mm long lineage head dissociate from size 50mm shell.Upon inspection, neither the shell lock ring nor the head showed any evidence of lock ring failure.Spoke with morgan bell regarding.

• Brand Name: GLADIATOR® BIPOLAR 50MM OD X 36MM 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: 15374471
• MDR Text Key: 299441321
• Report Number: 3010536692-2022-00319
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: M684GLBP36501
• UDI-Public: M684GLBP36501
• 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
• Report Date: 09/07/2022

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
• Device Operator: Health Professional
• Device Model Number: GLBP3650
• Device Catalogue Number: GLBP3650
• Device Lot Number: 1898268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/15/2022
• Initial Date Manufacturer Received: 08/15/2022
• Initial Date FDA Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Age: 79 YR