MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® FEMORAL RESURFACING HEAD 48MM; HIP COMPONENT

Model Number 38031048

Device Problems Particulates (1451); Patient-Device Incompatibility (2682)

Patient Problem Metal Related Pathology (4530)

Event Type  Injury  

Event Description

Allegedly, patient was revised due to adverse soft tissue reaction to particulate debris revision njr number: (b)(4).Side:l.Primary asa: p1 - fit and healthy.

• Brand Name: CONSERVE® FEMORAL RESURFACING HEAD 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: 15627125
• MDR Text Key: 301979137
• Report Number: 3010536692-2022-00365
• Device Sequence Number: 1
• Product Code: KXA
• UDI-Device Identifier: M684380310481
• UDI-Public: M684380310481
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K944752
• 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: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 38031048
• Device Catalogue Number: 38031048
• Device Lot Number: 58547904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/29/2022
• Date Manufacturer Received: 09/29/2022
• 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