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

Model Number PHAX12XX

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, patient was revised due to implant fracture - stem.However, the modular neck has likely fractured, not the stem.(b)(4).Side:r.Primary asa: p2 - mild disease not incapacitating.Components not revised: procotyl l beaded and ha coated cup size 54mm / product id: pha06264 / lot no.: 1412838.Rim-lock biolox delta ceramic liner 36mm id group e / product id: pha04510 / lot no.: 1400356.(b)(6) reference no: (b)(4).

• Brand Name: PROFEMUR MODULAR 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: 11668899
• MDR Text Key: 250354321
• Report Number: 3010536692-2021-00211
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

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: PHAX12XX
• Device Catalogue Number: PHAX12XX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/22/2021
• Initial Date Manufacturer Received: 03/22/2021
• Initial Date FDA Received: 04/14/2021
• Supplement Dates Manufacturer Received: 03/22/2021
• Supplement Dates FDA Received: 06/15/2021
• 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