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

Model Number 38SP5258

Device Problem Corroded (1131)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

See investigation attached.

Event Description

Allegedly, cocr corrosion claim (10+).Left side.

• Brand Name: CONSERVE® PLUS SPIKED 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: 17959123
• MDR Text Key: 326403911
• Report Number: 3010536692-2023-00180
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/18/2023

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: 38SP5258
• Device Catalogue Number: 38SP5258
• Device Lot Number: 0701155554
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/18/2023
• 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