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

Model Number PHA01232

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

This component is not commercially available in the us.

Event Description

Allegedly, patient was revised due to septic loosening component not revised: tige "anca fit?" rev.Hap 1/3 proximal 11g, ppr67606, lot u0579766.

• 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: 8850331
• MDR Text Key: 152920007
• Report Number: 3010536692-2019-00955
• 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
• Report Date: 08/01/2019

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: Health Professional
• Device Model Number: PHA01232
• Device Catalogue Number: PHA01232
• Device Lot Number: U0466567
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/02/2019
• Initial Date Manufacturer Received: 07/02/2019
• Initial Date FDA Received: 08/01/2019
• 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
• Patient Age: 69 YR