MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. UNKNOWN CONSERVE® PLUS CUP; HIP COMPONENT

Model Number 38XXXXXX

Device Problem Loss of Osseointegration (2408)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

See investigation attached.

Event Description

Allegedly, one study was received that was carried out in los angeles, california, in 2018 (is a cementless fixation of the femoral component suitable for metal-on-metal hip resurfacing arthroplasty?).This study was based on data collected from 2009 to 2013.From this data 76 patients were involved, of which 1 revision surgery was performed due to loosening of the acetabular component associated with high ion levels.

• Brand Name: UNKNOWN CONSERVE® PLUS CUP
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 19033891
• MDR Text Key: 339264589
• Report Number: 3010536692-2024-00154
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 38XXXXXX
• Device Catalogue Number: 38XXXXXX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 04/03/2024
• 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