MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. COCR TRANSCEND FEMORAL HEAD 36MM SLT TAPER SHORT; HIP COMPONENT

Model Number 26000025

Device Problems Material Disintegration (1177); Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 08/13/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, the patient was revised due to liner wear, disassociation and metallosis from metal on metal contact with the femoral head and acetabular component.(right hip).

• Brand Name: COCR TRANSCEND FEMORAL HEAD 36MM SLT TAPER SHORT
• 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: 12388315
• MDR Text Key: 268879654
• Report Number: 3010536692-2021-00456
• Device Sequence Number: 1
• Product Code: JDL
• UDI-Device Identifier: M684260000251
• UDI-Public: M684260000251
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K004043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 26000025
• Device Catalogue Number: 26000025
• Device Lot Number: 1509303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/11/2021
• Date Manufacturer Received: 08/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention