MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE A-CLASS BFH HEAD MEDIUM NECK 50MM; HIP COMPONENT

Model Number 38AM5000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Metal Related Pathology (4530)

Event Type  Injury  

Event 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.

• Brand Name: CONSERVE A-CLASS BFH HEAD MEDIUM NECK 50MM
• 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: 12393810
• MDR Text Key: 269223518
• Report Number: 3010536692-2021-00475
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: M68438AM50001
• UDI-Public: M68438AM50001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 38AM5000
• Device Catalogue Number: 38AM5000
• Device Lot Number: 077445943
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/11/2021
• Date Manufacturer Received: 08/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention