MAUDE Adverse Event Report: EXACTECH, INC. ALT XLE LNR EXTCOV G5 36; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	ALT XLE LNR EXTCOV G5 36
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	04/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: biolox delta femoral head 36mm od, +3.5mm (cat# 170-36-03 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 4 weeks postop the initial r tha, the female patient had symptoms of possible infection r hip.She was brought back for an irrigation debridement with a head and poly swap.This hip was dislocated, the femoral head was removed, the acetabular component exposed, the poly liner removed.After irrigation, a new poly liner and head was re implanted.Patient was last known to be in stable condition following the event.The device will not be returned for evaluation as the implants were discarded by hospital.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g7, h2, h3 and h6 have been updated accordingly.As reported, approximately 4 weeks postop the initial r tha, the female patient had symptoms of possible infection r hip.She was brought back for an irrigation debridement with a head and poly swap.This hip was dislocated, the femoral head was removed, the acetabular component exposed, the poly liner removed.After irrigation, a new poly liner and head was re implanted.Patient was last known to be in stable condition following the event.The device will not be returned for evaluation as the implants were discarded by hospital.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design, manufacturing, or patient related issues.The cause of the infection and subsequent revision cannot be conclusively determined; however, it is most likely is related to the patient¿s underlying condition.

• Brand Name: ALT XLE LNR EXTCOV G5 36
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11729430
• Report Number: 1038671-2021-00188
• Device Sequence Number: 16971300
• Product Code: JDI
• UDI-Device Identifier: 10885862549945
• UDI-Public: 10885862549945
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

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 G5 36
• Device Catalogue Number: 01-030-42-0536
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability