MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ISO/SLT TAPER 26MM CC FEM HEAD +0MM NECK; HIP COMPONENT

Model Number 26012602

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Date 05/29/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, troubleshooting situation: bha on 3/13, completed rehabilitation and went home.At home, she said she had pain on her hip side while sleeping.When she was getting up, she forced herself to stand up and fell off.According to the patient, there was no strong impact such as a fall.Doctor's findings: revision was performed on thursday, 6/1, and the bipolar cup, head, and neck were replaced.The same size as the original was re-replaced.The neck and head are fine, but there are some scratches on the polyethylene part of the rim of the bipolar cup.There is a possibility that some impingement may have occurred.The locking mechanism did not seem to have any problems.Japan (b)(4).

• Brand Name: ISO/SLT TAPER 26MM CC FEM HEAD +0MM NECK
• 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: 17936843
• MDR Text Key: 325679500
• Report Number: 3010536692-2023-00125
• Device Sequence Number: 1
• Product Code: LZO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 26012602
• Device Catalogue Number: 26012602
• Device Lot Number: 1952431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2023
• 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
• Patient Age: 57 YR
• Patient Sex: Female