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

Model Number PHA00236

Device Problems Failure to Osseointegrate (1863); Mechanical Jam (2983)

Patient Problem Insufficient Information (4580)

Event Date 11/09/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, unable to remove the neck, the entire stem was removed.Reporting party's findings and response status: there may have been impurities in the neck-stem joint, or the stem may have stuck due to cold flow.Additional information received on 2023-11-09: during neck removal, the stem came out unintentionally (is it possible that the fixation of the stem to the bone was insufficient).Additional information received on 2023-11-13: the primary reason for revision involved loosening of a non-mpo cemented cup.During this surgery, the plan was to revise the neck and head unless infection/loosening of the stem was also found.No infection was found, and only the neck was to be removed.However, the surgical team could not remove the neck from the stem which resulted in full revision of the femoral stem as well.Japan (b)(4).

• Brand Name: PROFEMUR® Z STEM
• 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: 18210481
• MDR Text Key: 329028997
• Report Number: 3010536692-2023-00218
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: M684PHA002361
• UDI-Public: M684PHA002361
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PHA00236
• Device Catalogue Number: PHA00236
• Device Lot Number: 12012554898
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2023
• 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 Age: 61 YR
• Patient Sex: Female