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

Model Number PHA0-1254

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Allegedly the patient was revised due to mom complications.Left.Update 10/09/2019: instructed dr davis that the current neck need to come out due to possible failure neck would not come out the instruments that we had both dr davis chuck tried to extract it.I told them to stop because we could break the extracting device for got trials liners so they wasted one strecker dual mobility liner was used with our head.

• 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: 10082995
• MDR Text Key: 191833856
• Report Number: 3010536692-2020-00372
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012541
• UDI-Public: M684PHA012541
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PHA0-1254
• Device Catalogue Number: PHA0-1254
• Device Lot Number: 096376582
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/15/2019
• Date Manufacturer Received: 10/15/2019
• 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