MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® TOTAL A-CLASS® 42MM FEMORAL HEAD; HIP COMPONENT

Model Number 38AC4200

Device Problems Material Fragmentation (1261); Patient Device Interaction Problem (4001)

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

Event Type  Injury  

Event Description

Allegedly, the patient had metal-on-metal hip arthroplasty that has been painful for 4 years.After reviewing his radiographs and operative report the chromic cobalt levels were all significantly elevated.There was mild evidence of corrosion at the trunnion of the base of the modular neck however it was very minimal and on the inside of the femoral component it was almost completely absent.The femoral components had metallic debris.

• Brand Name: CONSERVE® TOTAL A-CLASS® 42MM 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: 14025956
• MDR Text Key: 289429841
• Report Number: 3010536692-2022-00107
• Device Sequence Number: 1
• Product Code: JDL
• UDI-Device Identifier: M68438AC42001
• UDI-Public: M68438AC42001
• 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: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 38AC4200
• Device Catalogue Number: 38AC4200
• Device Lot Number: 1503304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/15/2022
• Date Manufacturer Received: 03/15/2022
• 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 Age: 76 YR
• Patient Sex: Male