MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 38MM HUMERAL LINER +0

Catalog Number 320-38-00

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); No Code Available (3191)

Event Date 08/23/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

As reported, a female patient, who was initially implanted on (b)(6) 2018 had a revision surgery on (b)(6) 2018 for a poly exchange where the surgeon removed item the liner and replaced it with a new liner.All available information has been received.

Event Description

This female patient was initially implanted on (b)(6) 2018.Approximately one (1) month post implant ((b)(6) 2018), the patient¿s original humeral liner (cat # 308-09-12 / sn# (b)(6) ) was replaced with an equinoxe reverse 38mm humeral liner +0 (cat# 320-38-00, sn# (b)(6) ) due to suspected infection.The surgeon opened the joint in standard fashion and removed all implants.He then cleaned out the joint to get rid of any infection, he then inserted new implants of the same size.The joint was closed in standard fashion.The patient left the or in stable condition and is expected to have a good outcome.Hospital did not release implants to be returned to exactech.

Manufacturer Narrative

Section h10: (h3) 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 infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.(h6) evaluation codes: 1735, 2993.Section h11: the following sections have corrected information: (b5) this female patient was initially implanted on (b)(6) 2018.Approximately one (1) month post implant ((b)(6) 2018), the patient¿s original humeral liner (cat # 308-09-12 / sn# (b)(6) ) was replaced with an equinoxe reverse 38mm humeral liner +0 (cat# 320-38-00, sn# (b)(6) ) due to suspected infection.The surgeon opened the joint in standard fashion and removed all implants.He then cleaned out the joint to get rid of any infection, he then inserted new implants of the same size.The joint was closed in standard fashion.The patient left the or in stable condition and is expected to have a good outcome.Hospital did not release implants to be returned to exactech.

• Brand Name: EQUINOXE
• Type of Device: REVERSE 38MM HUMERAL LINER +0
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9474256
• MDR Text Key: 170933380
• Report Number: 1038671-2019-00605
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086655
• UDI-Public: 10885862086655
• Combination Product (y/n): N
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2022
• Device Catalogue Number: 320-38-00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention