MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® PRESERVE CLASSIC; HIP COMPONENT

Model Number PPRCLS04

Device Problems Crack (1135); Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 09/23/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, periprosthetic femoral stem fracture occurred during rehabilitation a few weeks after op on (b)(6).Physician's finding: the fracture was caused by a longitudinal split fracture on the lateral side of the femur, which may have been caused by stress on the lateral side when a load was applied.This was the initial finding.Reporting physician's findings and response status: when the femur was rasped in the super path, a crack may have already been in the femur.When approaching with the super path, the approach tends to be vertical or slightly lateral in direction.Also, due to the stem shape characteristic of the preserve stem, when the stem is straight or outwardly bent, it is likely that a large size is inserted or stress is applied to the outer side of the stem.Products no revised: product id: pha04412, lot: 1900043, qty: 1, product id: p3sbmc50, lot: 1874728, qty: 1, product id: p2lelc32, lot: 1854672, qty: 1, product id: mstcbm20, lot: 1917612, qty: 1.Japan-(b)(4).

• Brand Name: PROFEMUR® PRESERVE CLASSIC
• 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: 15743867
• MDR Text Key: 303181074
• Report Number: 3010536692-2022-00398
• Device Sequence Number: 1
• Product Code: LZO
• 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,Followup
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PPRCLS04
• Device Catalogue Number: PPRCLS04
• Device Lot Number: 1856921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/26/2022
• Date Manufacturer Received: 10/26/2022
• 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