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

Model Number PHA01256

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 11/15/2017

Event Type  Injury  

Manufacturer Narrative

This complaint will be updated once investigation is complete.Trends will be evaluated.

Event Description

Allegedly the patient was revised due to modular neck fracture.

Manufacturer Narrative

This incident was re-investigated after further information, including product information, was received through legal on 09/23/2019.Updated incident description, incident, implant and explant dates; device information including lot number and initial reporter information.

Event Description

Allegedly the patient was revised due to modular neck fracture.Additional information received from legal on 09/23/2019: product id and lot information.Components not revised : dynasty biofoam shell - product id : dsbf-gd52, lot: 099911433 wright 6.5 mm canceilous self-tapping bone screw- product id : 1808-0301 lot: 128758307.Wright 6.5 mm cancellous self-tapping bone screw- product id : 1808-0302 lot: 036322041.Right hip.

• 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: 7151295
• MDR Text Key: 95936334
• Report Number: 3010536692-2017-01615
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2020

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: PHA01256
• Device Catalogue Number: PHA01256
• Device Lot Number: 12742729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/30/2017
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 11/30/2017; 11/30/2017
• Supplement Dates FDA Received: 02/20/2018; 10/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 69 YR