MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE A-CLASS BFH HEAD MEDIUM NECK 54MM; HIP COMPONENT

Model Number	38AM5400
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Reaction (2414)
Date of Event	12/03/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to left hip adverse local tissue reaction.

• Brand Name: CONSERVE A-CLASS BFH HEAD MEDIUM NECK 54MM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9787668
• Report Number: 3010536692-2020-00180
• Device Sequence Number: 11316777
• Product Code: LZO
• UDI-Device Identifier: M68438AM54001
• UDI-Public: M68438AM54001
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K021349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2020

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: 38AM5400
• Device Catalogue Number: 38AM5400
• Device Lot Number: 038552374
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/11/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 03/04/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 99