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

Model Number	38AM4604
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Reaction (2414); Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, for unknown reasons patient received a revision, she suffered physical injury, pain, bodily impairment, debilitating lack of mobility, high levels of toxic metal levels, conscious pain and suffering and loss of earnings resulting from the use of the metal-on-metal wright hip system.On 2006 patient underwent a left total hip replacement and received a metal on metal wright hip system orthopaedic implant.
Additional Manufacturer Narrative
Updated event problem codes to reflect the incident description.The investigation results are the same as initially reported.

• Brand Name: CONSERVE A-CLASS BFH HEAD SHORT NECK 46MM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9868389
• Report Number: 3010536692-2020-00264
• Device Sequence Number: 11490498
• Product Code: KWA
• UDI-Device Identifier: M68438AM46041
• UDI-Public: M68438AM46041
• 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: 2006
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2020

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: 38AM4604
• Device Catalogue Number: 38AM4604
• Device Lot Number: 086366642
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/03/2020
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 10/20/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention