MAUDE Adverse Event Report: TOTAL JOINT ORTHOPEDICS KLASSIC HD HIP SYSTEM; TOTAL HIP IMPLANTS

Catalog Number	3401.52.000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Original surgery was performed by dr.(b)(6) on (b)(6) 2024 (b)(6) hospital.Patient was on a trip in (b)(6) and was prepping for a standing photo on (b)(6) 2025 when her hip dislocated, she fell, was taken to a hospital in (b)(6), they performed a surgical reduction to put the hip back into place, they told her to rest for 9 days before coming back to the states.She went and saw (b)(6) on (b)(6) 2025 and then saw dr.(b)(6) on (b)(6) 2025.She is getting a follow up ct scan and is under the care of dr.(b)(6).Pending additional information from dr.(b)(6).This is the first reported incident involving these implants.Per dr.(b)(6), the patient's parts are well fixed and a ct scan confirmed positioning, the cup is a little vertical but within target range.Its a really strange story because it was doing great for over a year and then the story is it just popped out while she was standing on the beach.Dr.(b)(6) may revise the cup or put a constrained liner in the cup.The patient is still deciding on what she wants to do.
Event or Problem Description
Dislocated hip.Surgical reduction to correct a dislocation 13 months after original tha.

• Brand Name: KLASSIC HD HIP SYSTEM
• Common Device Name: TOTAL HIP IMPLANTS
• Manufacturer (Section D): TOTAL JOINT ORTHOPEDICS; 1567 east stratford avenue; salt lake city UT 84106
• Manufacturer Contact: kaisa cardall ; 1567 east stratford avenue; salt lake city, UT 84106 ; 8014866070
• MDR Report Key: 22187807
• Report Number: 3008544874-2025-00001
• Device Sequence Number: 8690610
• Product Code: LZO
• UDI-Device Identifier: 00814703017414
• UDI-Public: 00814703017414
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K220483
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 05/16/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 3401.52.000
• Device Lot Number: L230421-2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3511.52.036 LN Q221003-203206.36.700 LN M221004-1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female