MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR MODULAR FEMORAL NECK; HIP COMPONENT

Model Number PHA01244

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 02/10/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, sudden sagging and cracking of the hip, he could no longer strain.Neck broke.Additional information received on 02/17/2021: exact implanting date received (b)(6) 2009, and confirmation that the stem was not revised.Additional information received on 02/18/2021: lot number for the femoral head.Additional information received on 02/25/2021: incident description, components revised, implantation date (b)(6) 2009 and revision date (b)(6) 2021.Allegedly, the neck fractured.Additional information received on 02/26/2021: product id and lot number for femoral head, moreover confirmation that there were no deficiencies against this component.Component not revised: profemur e+ stem gr 5 product id: pha03165 (b)(6) case number: (b)(4).

Manufacturer Narrative

Updated incident description.

Event Description

Allegedly, sudden sagging and cracking of the hip, he could no longer strain.Neck broke.Additional information received on 02/17/2021: exact implanting date received (b)(6) 2009, and confirmation that the stem was not revised.Additional information received on 02/18/2021: lot number for the femoral head.Additional information received on 02/25/2021: incident description, confirmation of components revised, implantation and revision date.Allegedly, the neck fractured.Additional information received on 02/26/2021: confirmation of product id and lot number for femoral head, indication that there were no deficiencies against this component.Component not revised: profemur e+ stem gr 5 product id: pha03165.Bfarm case number: (b)(4).

• Brand Name: PROFEMUR MODULAR FEMORAL NECK
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11495213
• MDR Text Key: 252362775
• Report Number: 3010536692-2021-00157
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012441
• UDI-Public: M684PHA012441
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PHA01244
• Device Catalogue Number: PHA01244
• Device Lot Number: 028549482
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/26/2021
• Date Manufacturer Received: 02/26/2021
• Removal/Correction Number: Z-2941-2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 85