MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® A-CLASS® BFH® HEAD LONG NECK 46MM; HIP COMPONENT

Model Number	38AM4635
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Codes	Reaction (2414); No Information (3190)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, underwent surgery of a total prosthetic hip device on her left side, because of increasingly worsening problems with her left hip, following her 2010 surgery.Plaintiff underwent a second left hip surgery.The parts was unreasonably dangerous because the process in the body of the patient whereby metal components rubbered on other metal component parts and caused metal to break off of the system parts and become permanent contaminants within the patients bodies, including plaintiff herein and causing the patients permanent physical and systematic injury.
Additional Manufacturer Narrative
See attached - attachment: [wd011615-02.Pdf].

• Brand Name: CONSERVE® A-CLASS® BFH® HEAD LONG NECK 46MM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9150835
• Report Number: 3010536692-2019-01075
• Device Sequence Number: 2576400
• Product Code: KWA
• UDI-Device Identifier: M68438AM46351
• UDI-Public: M68438AM46351
• Combination Product (Y/N): N
• PMA/510(K) Number: K021349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2019

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: 38AM4635
• Device Catalogue Number: 38AM4635
• Device Lot Number: 049841532
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 02/21/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention