MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. COCR TRANSCEND FEMORAL HEAD 32MM SLT TAPER MEDIUM; HIP COMPONENT

Model Number 26000022

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

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

Event 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.

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 3010536692-2020-00205.

Event 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: COCR TRANSCEND FEMORAL HEAD 32MM SLT TAPER MEDIUM
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9817320
• MDR Text Key: 182910398
• Report Number: 3010536692-2020-00211
• Device Sequence Number: 1
• Product Code: JDL
• UDI-Device Identifier: M684260000221
• UDI-Public: M684260000221
• 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: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 26000022
• Device Catalogue Number: 26000022
• Device Lot Number: 15063261764012
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/17/2020
• Date Manufacturer Received: 02/17/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 95 YR