MAUDE Adverse Event Report: EXACTECH, INC. ALT XLE LNR EXTCOV G7 40; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	ALT XLE LNR EXTCOV G7 40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, a (b)(6) patient had right tha revision of the stem, head, and liner for an unknown reason.Alteon cup stayed and a new exactech extended coverage liner +40mm head was implanted.The stem and head were revised to a different company.No other implant information is known.There was no breakage of devices.There was 30-45 minute surgical delay/ prolongation.Patient was last known to be in stable condition following the event.X-rays were receive; however, the devices are not available for evaluation as implants that were removed were thrown away by the staff at the facility.
Additional Manufacturer Narrative
After further review of additional information received the following sections d1, d4, d6a, g3, g6, h2, h3 and h6 have been updated accordingly.(h3) as reported, a 82 y/o male patient had a right tha revision of the stem, head, and liner for an unknown reason.The alteon cup stayed and a new exactech extended coverage liner +40mm head was implanted.The stem and head were revised to a different company¿s devices.There was no breakage of devices.There was 30-45 minute surgical delay/prolongation.Patient was last known to be in stable condition following the event.X-rays were received; however, the devices are not available for evaluation as implants that were removed and thrown away by the staff at the facility.Additional information was requested and is not available.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.

• Brand Name: ALT XLE LNR EXTCOV G7 40
• 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: 13389500
• Report Number: 1038671-2022-00071
• Device Sequence Number: 14702134
• Product Code: JDI
• UDI-Device Identifier: 10885862550057
• UDI-Public: 10885862550057
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2022

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 Expiration Date: 08/28/2024
• Device Model Number: ALT XLE LNR EXTCOV G7 40
• Device Catalogue Number: 01-030-42-0740
• 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: 01/10/2022
• Supplement Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2019
• 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: 82 YR
• Patient Sex: Male