MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. GLADIATOR® BIPOLAR 51MM OD X 36MM ID; HIP COMPONENT

Model Number GLBP3651

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 05/08/2019

Event Type  Injury  

Manufacturer Narrative

This event will be updated when investigation is complete.

Event Description

Allegedly, primary surgery was preformed on (b)(6) 2016.The surgeon found a dissociation after surgery and mentioned excessive stress , may have occurred during agricultural work.The surgeon performed revision surgery on (b)(6) 2019.We will not return at this time.

Event Description

Allegedly, primary surgery was preformed on (b)(6) 2016.The surgeon found a dissociation after surgery and mentioned excessive stress, may have occurred during agricultural work.

• Brand Name: GLADIATOR® BIPOLAR 51MM OD X 36MM ID
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 8758299
• MDR Text Key: 149948708
• Report Number: 3010536692-2019-00892
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: M684GLBP36511
• UDI-Public: M684GLBP36511
• Combination Product (y/n): N
• PMA/PMN Number: K062693
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2020

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
• Device Operator: Other
• Device Model Number: GLBP3651
• Device Catalogue Number: GLBP3651
• Device Lot Number: 14697101591839
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/06/2019
• Initial Date Manufacturer Received: 06/06/2019
• Initial Date FDA Received: 07/03/2019
• Supplement Dates Manufacturer Received: 06/06/2019
• Supplement Dates FDA Received: 02/07/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR