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

Model Number 38AC4600

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 289682049
• Report Number: 3010536692-2022-00132
• Device Sequence Number: 1
• Product Code: JDL
• UDI-Device Identifier: M68438AC46001
• UDI-Public: M68438AC46001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female