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

Model Number PHA01204

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 09/30/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, the patient stumbled and fell while walking resulting in a neck fracture.Bfarm case number: (b)(4).

Event Description

Additional information obtained on (b)(6) 2020.Implant and revision dates.Additional components implanted.Implant surgery was extended to 43 minutes.Left hip.Components not revised: procotyl acetabular shell 56mm pha0-6266 lot 118673721.Acetabular liner 36mm pha0-4612 lot 099831001.

Manufacturer Narrative

Updated incident description, implant and explant dates.

• 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: 9532717
• MDR Text Key: 182357026
• Report Number: 3010536692-2019-01218
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012041
• UDI-Public: M684PHA012041
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 12/30/2019

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: 069874362
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/21/2019
• Initial Date Manufacturer Received: 10/21/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 10/21/2019; 10/21/2019
• Supplement Dates FDA Received: 02/28/2020; 04/22/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR