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

Model Number PHA01252

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Joint Dislocation (2374)

Event Date 07/27/2021

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.The bipolar cup fell off the head.T was confirmed that the soft tissue was wrapped around the ring part in the tumbled bipolar cup.(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
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 12360129
• MDR Text Key: 267887227
• Report Number: 3010536692-2021-00447
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012521
• UDI-Public: M684PHA012521
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/20/2021

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: PHA01252
• Device Catalogue Number: PHA01252
• Device Lot Number: 1850491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/30/2021
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/24/2021
• Supplement Dates Manufacturer Received: 07/30/2021
• Supplement Dates FDA Received: 10/20/2021
• 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
• Patient Age: 65 YR