MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; WALKER,2 BUTTON,ADULT,5" FIXED WHEE

Catalog Number MDS86410W54B

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bone Fracture(s) (1870); Joint Dislocation (2374)

Event Date 07/21/2023

Event Type  Injury  

Event Description

According to the customer on (b)(6) 2023 her mother was "walking through the entry hallway and felt a give out effect and fell".

Manufacturer Narrative

According to the customer on (b)(6) 2023 her mother was "walking through the entry hallway and felt a give out effect and fell".Per the customer her mother called 911 and was transported to the emergency room where she was diagnosed with a "dislocation of her new hip replacement, spiral fracture to the left femur, and 5 fractures to the greater trochanter of the femur bone".Per the customer her mother "would need surgery and non-weight bearing for 6 weeks".Per the customer her mother was using the device beginning on (b)(6) after she was discharged from the hospital post total hip replacement on (b)(6).Per the customer "the back left leg was bent, and that is the direction of the give out that her mother experienced".The device has been requested for evaluation.No additional information is available at this time.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Manufacturer Narrative

Updated: d4, g3, g6, h6.

• Type of Device: WALKER,2 BUTTON,ADULT,5" FIXED WHEE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17641583
• MDR Text Key: 322164703
• Report Number: 1417592-2023-00356
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86410W54B
• Device Lot Number: 88522090002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention