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 upload once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, patient fell again, dislocated and the bipolar disassociated.There has not been a confirmed revision for this incident.Reference (b)(4) as a previous incident for this patient.
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 after revision.This event was also captured under report 3010536692-2020-00211.
Event or Problem Description
Allegedly, patient fell and bipolar shell disassociated for the first time.Patient came back and a revision was done, new shell and head put in.Patient fell again and dislocated, when surgeon went to reduce the hip again the new components again disassociated.

• 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: 9813958
• Report Number: 3010536692-2020-00205
• Device Sequence Number: 19527518
• 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
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2020

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: 1818957
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 09/21/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention