MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® RENAISSANCE® STEM; HIP COMPONENT

Model Number PLS0R416

Device Problems Corroded (1131); Naturally Worn (2988)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Event Description

Allegedly, on (b)(6), 2017, patient had a left total hip arthroplasty.Patient received the profemur short cobalt chrome modular neck (phac1252) and a profemur renaissance femoral stem made of titanium alloy.Patient now experiences on-going pain and has been told he is in need of revision surgery due to "metal-on-metal wear" and that his cobalt and chromium levels are elevated.Due to failure of his device, patient is in the process of scheduling a revision surgery to remove the defective device.It has been stated also that the profemur total hip system implanted on patient's left side has subsequently failed due to corrosion of the modular neck.The date of the revision surgery has not been indicated and it has not been confirmed that the revision surgery has already been performed.

Manufacturer Narrative

Section d.4: additional information in product id and lot # added./ section e.1: additional information in hospital added.

• Brand Name: PROFEMUR® RENAISSANCE® STEM
• 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: 15864750
• MDR Text Key: 304286279
• Report Number: 3010536692-2022-00421
• 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: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PLS0R416
• Device Catalogue Number: PLS0R416
• Device Lot Number: 1595721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/01/2022
• Date Manufacturer Received: 11/01/2022
• 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