MAUDE Adverse Event Report: EXACTECH, INC. ALTEON CUP, CLSTR HOLE G6, SIZE 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	ALT XLE LNR EXTCOV G6 40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant devices: biolox delta femoral head 40mm od, +7mm (cat# 170-40-07).Cup (cat# 01-030-10-0654 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately six months postop the initial ltha, this (b)(6) male patient was revised due to a peri prosthetic fracture.Patient was last known to be in stable condition following the event.The device will not be returned for evaluation due to hospital policy.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g7, h2 and h6 have been updated accordingly.As reported, approximately six months postop the initial ltha, this 79 y/o male patient was revised due to a peri prosthetic fracture.Patient was last known to be in stable condition following the event.The device will not be returned for evaluation due to hospital policy.These devices were used for treatment, not diagnosis.A known surgical risk for total hip revision is potential bone fracture.As part of the preoperative assessment, the surgeon must ensure that no biological, biomechanical, or other factors exist that might adversely affect the surgery and/or postoperative period.The most likely cause for the bone fracture possibly surgical technique and patient conditions at the time of implantation of the total hip components.

• Brand Name: ALTEON CUP, CLSTR HOLE G6, SIZE 54MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 12342159
• Report Number: 1038671-2021-00399
• Device Sequence Number: 3515717
• Product Code: JDI
• UDI-Device Identifier: 10885862550002
• UDI-Public: 10885862550002
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/15/2022

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 Model Number: ALT XLE LNR EXTCOV G6 40
• Device Catalogue Number: 01-030-101-0654
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 09/21/2021; 09/21/2021
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 10/19/2021; 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 107 KG