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

Model Number	GLBP3650
Medical Device Problem Code	No Fail-Safe Mechanism (2990)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2022
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: 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
• Report Number: 3010536692-2022-00319
• Device Sequence Number: 17597420
• Product Code: KWY
• UDI-Device Identifier: M684GLBP36501
• UDI-Public: M684GLBP36501
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K062693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 09/07/2022
• 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
• Patient Age: 79 YR
• Patient Sex: Unknown