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

Model Number 38AM4000

Device Problem Material Disintegration (1177)

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

Event Type  Injury  

Event 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.

Manufacturer Narrative

Section b5: additional information in description / section b5: explant date added / section h6 health code 4530 added.

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.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
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10474403
• MDR Text Key: 205128554
• Report Number: 3010536692-2020-00594
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: M68438AM40001
• UDI-Public: M68438AM40001
• Combination Product (y/n): N
• PMA/PMN Number: K021349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 08/17/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention