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

Model Number PHA01204

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Date 12/15/2017

Event Type  Injury  

Manufacturer Narrative

Investigation completed.Evaluation codes added.

Event Description

Allegedly, the patient's acetabular components were revised on (b)(6) 2008 due to rotational instability, and a hematoma was found and removed during the operation (incident group #(b)(4)).On (b)(6) 2017, the patient experienced a modular neck fracture.All components were removed during this revision on (b)(6) 2017.

• 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: 10502720
• MDR Text Key: 205938027
• Report Number: 3010536692-2020-00607
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012041
• UDI-Public: M684PHA012041
• 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: Physician
• Type of Report: Initial
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PHA01204
• Device Catalogue Number: PHA01204
• Device Lot Number: 018525557
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/19/2020
• Date Manufacturer Received: 08/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 118