MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE A-CLASS BFH HEAD MEDIUM NECK 40MM; HIP COMPONENT

Model Number	38AM4000
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient underwent a right total hip replacement and received a metal on metal wright hip system implants.Patient suffered pain, debilitating lack of mobility, and high levels of toxic metal levels.
Additional Manufacturer Narrative
Section b5: additional information in description / section b5: explant date added / section h6 health code 4530 added.
Event or Problem Description
Allegedly, patient underwent a left total hip replacement and received a metal on metal hip system implants.Patient suffered pain, debilitating lack of mobility, and high levels of toxic metal levels.Additional information received on 08/11/2021 from legal department: adding revision surgery date for right hip on (b)(6) 2020).

• Brand Name: CONSERVE A-CLASS BFH HEAD MEDIUM NECK 40MM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10474403
• Report Number: 3010536692-2020-00594
• Device Sequence Number: 3274071
• Product Code: KWA
• UDI-Device Identifier: M68438AM40001
• UDI-Public: M68438AM40001
• 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: 2007
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2021

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: 38AM4000
• Device Catalogue Number: 38AM4000
• Device Lot Number: 017395737
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/17/2020
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 11/04/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention