MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. GLADIATOR BIPOLAR 49MM OD X 32MM ID; HIP COMPONENT

Model Number	GLBP3249
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, the patient fell and dislocated, during closed reduction the bipolar disassociated, and then the patient was revised.Reference (b)(4).
Additional Manufacturer Narrative
Updated information related to the patient, implant date and initial reporter.This report references the dislocation and disassociation suffered by the patient before revision.The event was also captured under report 3010536692-2020-00226.A related event for this patient was captured under report 3010536692-2020-00211 & 3010536692-2020-00205.
Additional Manufacturer Narrative
Corrected implant and explant dates.There was a confusion on the previous report.

• Brand Name: GLADIATOR BIPOLAR 49MM OD X 32MM ID
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9821721
• Report Number: 3010536692-2020-00225
• Device Sequence Number: 14220349
• Product Code: KWY
• UDI-Device Identifier: M684GLBP32491
• UDI-Public: M684GLBP32491
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K062693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2020

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: Other
• Device Model Number: GLBP3249
• Device Catalogue Number: GLBP3249
• Device Lot Number: 1713156
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/21/2020
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 02/21/2020; 02/21/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 09/21/2020; 09/22/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention