MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE A-CLASS BFH HEAD SHORT NECK 50MM; HIP COMPONENT

Model Number	38AM5004
Medical Device Problem Codes	Corroded (1131); Material Disintegration (1177)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to metal debris, corrosion and metal ions.

• Brand Name: CONSERVE A-CLASS BFH HEAD SHORT NECK 50MM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11731234
• Report Number: 3010536692-2021-00247
• Device Sequence Number: 3192924
• Product Code: KWA
• UDI-Device Identifier: M68438AM50041
• UDI-Public: M68438AM50041
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K021349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/27/2021

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: 38AM5004
• Device Catalogue Number: 38AM5004
• Device Lot Number: 077447836
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 04/27/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention