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

Model Number	38AM5035
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Reaction (2414)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to metal on metal complications of his left hip.

• Brand Name: CONSERVE A-CLASS BFH HEAD LONG NECK 50MM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10268140
• Report Number: 3010536692-2020-00480
• Device Sequence Number: 3399449
• Product Code: KWA
• UDI-Device Identifier: M68438AM50351
• UDI-Public: M68438AM50351
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2020

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: Other
• Device Model Number: 38AM5035
• Device Catalogue Number: 38AM5035
• Device Lot Number: 019778610
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/21/2020
• Initial Date Received by Manufacturer: 06/21/2020
• Supplement Date Received by Manufacturer: 06/21/2020
• Initial Report FDA Received Date: 07/13/2020
• Supplement Report FDA Received Date: 07/16/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention