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

Model Number	38AC4600
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, plaintiff received a wright hip system on (b)(6) 2010.After implantation of the wright hip system, plaintiff began suffering persistent pain and decreased mobility, both worsening over time.Plaintiffs wright hip system detached, disconnected, created metallic debris, released metal ions, and/or loosened from plaintiff? acetabulum, loosening through osteolysis, inflammation causing damage or death to tissue and bone around the implant and metallosis.On (b)(6) 2021, plaintiff was required to undergo revision surgery to remove and replace wright hip system.

• Brand Name: CONSERVE® TOTAL A-CLASS® 46MM FEMORAL HEAD
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 14160306
• Report Number: 3010536692-2022-00132
• Device Sequence Number: 2846038
• Product Code: JDL
• UDI-Device Identifier: M68438AC46001
• UDI-Public: M68438AC46001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051348
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/20/2022

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: 38AC4600
• Device Catalogue Number: 38AC4600
• Device Lot Number: 069867731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/29/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female