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

Model Number PHA01234

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, after a right hip arthroplasty, patient was revised due to pain.Revision surgery was performed in 2018 in (b)(6).(b)(6) reference no: (b)(4).

Manufacturer Narrative

10.Additional narrative: void report - no complaint stated against the device 11.Corrected data: 6.Adverse event problem (refer to coding manual) medical device problem code 2993.

• 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: 12127564
• MDR Text Key: 260416988
• Report Number: 3010536692-2021-00352
• 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: 08/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PHA01234
• Device Catalogue Number: PHA01234
• Device Lot Number: S10116276
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/15/2021
• Date Manufacturer Received: 06/15/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention