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

Model Number	26000022
Health Effect - Clinical Code	Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, the patient had metal on metal complications.

• Brand Name: COCR TRANSCEND FEMORAL HEAD 32MM SLT TAPER MEDIUM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11300680
• Report Number: 3010536692-2021-00060
• Device Sequence Number: 11605113
• Product Code: JDL
• UDI-Device Identifier: M684260000221
• UDI-Public: M684260000221
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K004043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 26000022
• Device Catalogue Number: 26000022
• Device Lot Number: 114112742
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/27/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 02/09/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention