MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. GLADIATOR® BIPOLAR 44MM OD X 28MM ID; HIP COMPONENT

Model Number GLBP2844

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem Prolapse (2475)

Event Date 05/20/2022

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Event Description

Allegedly, revision was performed for a case of prolapse.The bipolar cup side was damaged before revision, causing the patient's prolapse.Doctor's finding: the bipolar cup side was damaged (ring deformation) before the revision, which may have caused the patient's prolapse.Reporting party's findings and response: the ring in the outer cup was deformed and seemed to be loose, so the cup and head were replaced.(b)(6) - oc000000297.

• Brand Name: GLADIATOR® BIPOLAR 44MM OD X 28MM 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: 14799877
• MDR Text Key: 295058643
• Report Number: 3010536692-2022-00231
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: M684GLBP28441
• UDI-Public: M684GLBP28441
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062693
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2022

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: Other
• Device Model Number: GLBP2844
• Device Catalogue Number: GLBP2844
• Device Lot Number: 1571995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/31/2022
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 06/24/2022
• Supplement Dates Manufacturer Received: 05/31/2022
• Supplement Dates FDA Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention