MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® TL STEM SZ 6; HIP COMPONENT

Model Number PRTL0026

Device Problem Difficult to Insert (1316)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/18/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, there was a case of bha at nishinara central hospital, where tlbha was scheduled and tl was rasped up to 6.Tl6 was used for genuine insertion, but when the implant was placed, it floated about 3mm, and when it was placed to the proper height, bone cracking occurred.The implant was removed with an extractor and replaced with an xm, and the op was successfully completed.(b)(4).

• Brand Name: PROFEMUR® TL STEM SZ 6
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 19129884
• MDR Text Key: 340449084
• Report Number: 3010536692-2024-00264
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: M684PRTL00261
• UDI-Public: M684PRTL00261
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K060358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2024

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: Health Professional
• Device Model Number: PRTL0026
• Device Catalogue Number: PRTL0026
• Device Lot Number: 17570101908962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention