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

Model Number PHA01234

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

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 dislocation , subluxation and malalignment stem.Revision njr number: 4502611.Side:r.Primary asa: p2 - mild disease not incapacitating.No information provided for stem.Additional information received on 10/08/2020 from (b)(6): adding a new incident for the stem with partial product information.

Event Description

Allegedly, patient was revised due to dislocation , subluxation and malalignment stem.Revision njr number: 4502611.Side:r.Primary asa: p2 - mild disease not incapacitating.No information provided for stem.Additional information received on 10/08/2020 from (b)(6): adding a new incident for the stem with partial product information.Additional information received on 11/09/2020 from (b)(6) : adding stem product number and lot batch.Mhra reference no: (b)(4).

• 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: 10765619
• MDR Text Key: 214090903
• Report Number: 3010536692-2020-00673
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012341
• UDI-Public: M684PHA012341
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

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: PHA01234
• Device Catalogue Number: PHA01234
• Device Lot Number: 097473779
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/08/2020
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 10/30/2020
• Supplement Dates Manufacturer Received: 10/08/2020
• Supplement Dates FDA Received: 01/08/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention