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

Model Number PHA01204

Device Problem Break (1069)

Patient Problem Discomfort (2330)

Event Date 12/13/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, the modular neck has fractured.Additional information received on 01/29/2021: adding exact incident date and incident description.Allegedly, when going for a walk on (b)(6) 2020, the patient felt a "cracking" in the area of the left hip, whereupon he could no longer strain the left lower extremity.Basg ref.No (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
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 11335211
• MDR Text Key: 232322748
• Report Number: 3010536692-2021-00080
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012041
• UDI-Public: M684PHA012041
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

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: Other
• Device Model Number: PHA01204
• Device Catalogue Number: PHA01204
• Device Lot Number: V11276720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/29/2021
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/16/2021
• Supplement Dates Manufacturer Received: 01/29/2021
• Supplement Dates FDA Received: 04/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Removal/Correction Number: Z-2941-2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 86