MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. COCR TRANSCEND® FEMORAL HEAD 28MM SLT TAPER SHORT; HIP COMPONENT

Model Number	26000017
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	Reaction (2414)
Date of Event	05/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly the patient was revised due to mom complications: metallosis.

• Brand Name: COCR TRANSCEND® FEMORAL HEAD 28MM SLT TAPER SHORT
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 8736890
• Report Number: 3010536692-2019-00839
• Device Sequence Number: 16672989
• Product Code: JDL
• UDI-Device Identifier: M684260000171
• UDI-Public: M684260000171
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K004043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/24/2019

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: 26000017
• Device Catalogue Number: 26000017
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/31/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 06/26/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR