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

Model Number PHA01202

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, a patient was revised due to dislocation.Components not revised: product name: profemur(r) proximal body part id: ppw39102.Product name: profemur(r) roughened distal stem, tapered part id: ppw38026.

Manufacturer Narrative

Due to additional information received on 09/02/2021 from initial reporter (b)(6), the device pha01202 mentioned on the initial report has been replaced by the device pha04414.The site stated they used a non-mpo femoral head.Therefore, the incident with part id: pha04414 and part name femoral head biolox delta ceramic 12/14 - 36 s, needs to be voided.Please void this report.

• 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: 12430959
• MDR Text Key: 270061261
• Report Number: 3010536692-2021-00503
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012021
• UDI-Public: M684PHA012021
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PHA01202
• Device Catalogue Number: PHA01202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/12/2021
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 09/06/2021
• Supplement Dates Manufacturer Received: 08/12/2021
• Supplement Dates FDA Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1