MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. COCR SF FEM HEAD 36MM SLT TPR MED NK IMPLANT PARTN; HIP COMPONENT

Model Number 26000026WD

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 01/30/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, bipolar became disassociated and a revision surgery to an slt bipolar happened.

Manufacturer Narrative

Updated incident description.

Event Description

Allegedly, bipolar became disassociated and a revision surgery to an slt bipolar happened.Information collected from invoice search on (b)(6) 2021: implant date.

• Brand Name: COCR SF FEM HEAD 36MM SLT TPR MED NK IMPLANT PARTN
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11402015
• MDR Text Key: 234392449
• Report Number: 3010536692-2021-00132
• Device Sequence Number: 1
• Product Code: JDL
• UDI-Device Identifier: M68426000026WD1
• UDI-Public: M68426000026WD1
• Combination Product (y/n): N
• PMA/PMN Number: K004043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 26000026WD
• Device Catalogue Number: 26000026WD
• Device Lot Number: 1520395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/11/2021
• Date Manufacturer Received: 02/11/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention