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 No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Investigation completed.Evaluation codes added.

Event Description

Allegedly, patient was revised due to prosthesis dislocation.Components not revised: cotyle "anca" avec trous a/revet.Hap 62 ppr67262 lot s07108479.Tige "anca fit?" rev.Hap 1/3 proximal 11g ppr67606 lot s07108935.Noyau "anca fit?"10 deg.62*28 ppr67562 lot s06108481.

Manufacturer Narrative

Evaluation codes updated.- attachment: [19070916fdatimingletterupdates.Pdf].

• 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: 10257641
• MDR Text Key: 206139773
• Report Number: 3010536692-2020-00475
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012021
• UDI-Public: M684PHA012021
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PHA01202
• Device Catalogue Number: PHA01202
• Device Lot Number: T03121744
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/02/2019
• Date Manufacturer Received: 07/02/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 65 YR