MAUDE Adverse Event Report: AESCULAP AG Biolox® forte; Prosthesis, hip, semi-constrained, metal/polymer, uncemented

Model Number	NK562
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
An adverse event was reported involving the aesculap knee implants.Specifically, it was reported that following hip surgery in 2017, the patient experienced a fall.Subsequent evaluation reportedly identified a fracture of the implanted medical device.Revision surgery is required.The surgery was performed in argentina, at (b)(6) hospital, but the patient currently lives and is in (b)(6).This report is filed under ais reference (b)(4).

• Brand Name: Biolox® forte
• Common Device Name: Prosthesis, hip, semi-constrained, metal/polymer, uncemented
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 25734526
• Report Number: 25734526
• Device Sequence Number: 18744990
• Product Code: LWJ
• UDI-Device Identifier: 04038653120079
• UDI-Public: (01)04038653120079(11)150727(17)250630(10)52162938
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2026
• Report Date (Section F): 08/17/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: NK562
• Device Catalogue Number: NK562
• Device Lot Number: 52162938
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/17/2026
• Device Age: 133 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/17/2026
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/07/2026
• Supplement Report FDA Received Date: 08/17/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Date Report Sent to FDA: 07/07/2026