MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE A-CLASS BFH HEAD LONG NECK 44MM; HIP COMPONENT

Model Number	38AM4435
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, revision surgery was necessary because the device failed due to adverse tissue reaction to metal debris, corrosion and resultant metal ions.Left hip.

• Brand Name: CONSERVE A-CLASS BFH HEAD LONG NECK 44MM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10971244
• Report Number: 3010536692-2020-00737
• Device Sequence Number: 791231
• Product Code: KWA
• UDI-Device Identifier: M68438AM44351
• UDI-Public: M68438AM44351
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2020

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: 38AM4435
• Device Catalogue Number: 38AM4435
• Device Lot Number: 0401098047
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/19/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 12/08/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention