MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® NECK VAR/VAL 8DG LONG COBALT CHROME; HIP COMPONENT

Model Number PHAC1254

Device Problem Break (1069)

Patient Problem Fall (1848)

Event Date 05/21/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, px was admitted to hospital after he fell at home and the x-rays showed the implant fracture.Surgeon does not know how he came to fell i.E.If he stumbled and fell or if the implant failed and he fell because of that.A revision surgery was required to make a stem change.Bfarm case number: (b)(4).

• Brand Name: PROFEMUR® NECK VAR/VAL 8DG LONG COBALT CHROME
• 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: 14835696
• MDR Text Key: 295057754
• Report Number: 3010536692-2022-00236
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: M684PHAC12541
• UDI-Public: M684PHAC12541
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K091423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/18/2022

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: PHAC1254
• Device Catalogue Number: PHAC1254
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/07/2022
• Initial Date Manufacturer Received: 06/07/2022
• Initial Date FDA Received: 06/27/2022
• Supplement Dates Manufacturer Received: 06/07/2022
• Supplement Dates FDA Received: 08/18/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male