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 09/07/2019

Event Type  Injury  

Event Description

Allegedly, patient was revised for a broken neck.

Manufacturer Narrative

Additional information for this event was received on 02/05/2021 through a legal claim.Description and contact name were updated.The previous investigation remains valid.

Event Description

Allegedly, patient was revised for a broken neck.Additional information received on 02/05/2021: allegedly, on the revision surgery dr.(b)(6) also found a pseudo-tumor.

• 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: 9664564
• MDR Text Key: 177577650
• Report Number: 3010536692-2019-01083
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• 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: 057436027
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/10/2019
• Date Manufacturer Received: 09/10/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 91