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

Model Number	26000023
Health Effect - Clinical Code	Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to adverse soft tissue reaction to particulate debris revision njr number: (b)(4), side:r, primary asa: p2 - mild disease not incapacitating.

• Brand Name: COCR TRANSCEND FEMORAL HEAD 32MM SLT TAPER LONG N
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 12275370
• Report Number: 3010536692-2021-00421
• Device Sequence Number: 11885994
• Product Code: JDL
• UDI-Device Identifier: M684260000231
• UDI-Public: M684260000231
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K004043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2021

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: 26000023
• Device Catalogue Number: 26000023
• Device Lot Number: 87459184
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 08/04/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention