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

Model Number 26000022

Device Problem Material Fragmentation (1261)

Patient Problem Metal Related Pathology (4530)

Event Type  Injury  

Event Description

Allegedly, the patient had metal on metal complications.

• 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
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 11300680
• MDR Text Key: 230941071
• Report Number: 3010536692-2021-00060
• Device Sequence Number: 1
• Product Code: JDL
• UDI-Device Identifier: M684260000221
• UDI-Public: M684260000221
• 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: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 26000022
• Device Catalogue Number: 26000022
• Device Lot Number: 114112742
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/27/2021
• Date Manufacturer Received: 01/27/2021
• 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