MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® A-CLASS® BFH® HEAD LONG NECK 48MM; HIP COMPONENT

Model Number 38AM4835

Device Problem Output Problem (3005)

Patient Problem Metal Related Pathology (4530)

Event Type  Injury  

Event Description

Allegedly, the patient is experiencing mom complications (left).Additional information received on 01/21/2022.Allegedly, patient underwent index surgery on his left hip on (b)(6) 2010 at (b)(6) hospital in (b)(6).Patient subsequently underwent revision surgery on his left hip at (b)(6) hospital on (b)(6) 2020.This is an alleged dynasty® mom case.

• Brand Name: CONSERVE® A-CLASS® BFH® HEAD LONG NECK 48MM
• 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: 13453734
• MDR Text Key: 287611773
• Report Number: 3010536692-2022-00039
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: M68438AM48351
• UDI-Public: M68438AM48351
• 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: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 38AM4835
• Device Catalogue Number: 38AM4835
• Device Lot Number: 078648164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/21/2022
• Date Manufacturer Received: 01/21/2022
• 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: Male