MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® A-CLASS® BFH® HEAD LONG NECK 38MM; HIP COMPONENT

Model Number	38AM3835
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to cocr corrosion.

• Brand Name: CONSERVE® A-CLASS® BFH® HEAD LONG NECK 38MM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10087692
• Report Number: 3010536692-2020-00379
• Device Sequence Number: 2461477
• Product Code: KWA
• UDI-Device Identifier: M68438AM38351
• UDI-Public: M68438AM38351
• 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: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2020

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: 38AM3835
• Device Catalogue Number: 38AM3835
• Device Lot Number: 1508794
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/04/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 05/26/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention