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

Model Number 26000022

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Metal Related Pathology (4530)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, patient revised due to evidence of pseudotumor and corrosion.Changes on the female side of the taper and on the male side to a lesser degree (right hip).

Manufacturer Narrative

Corrected data section h.6.Adverse event problem: codes updated.

• 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: 12178721
• MDR Text Key: 261886741
• Report Number: 3010536692-2021-00401
• 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: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 09/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• 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: 1414825
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/21/2021
• Date Manufacturer Received: 06/21/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention