MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® A-CLASS® BFH® HEAD SHORT NECK 48MM; HIP COMPONENT

Model Number	38AM4804
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Reaction (2414)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to metal on metal complications.

• Brand Name: CONSERVE® A-CLASS® BFH® HEAD SHORT NECK 48MM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10081135
• Report Number: 3010536692-2020-00371
• Device Sequence Number: 14419742
• Product Code: KWA
• UDI-Device Identifier: M68438AM48041
• UDI-Public: M68438AM48041
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K021349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2020

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: 38AM4804
• Device Catalogue Number: 38AM4804
• Device Lot Number: 059864564
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/29/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 05/21/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention