MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE HUMERAL ADAPTER TRAY

Catalog Number 320-10-00

Device Problems Contamination (1120); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 12/08/2017

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Revision due to infection.

Manufacturer Narrative

After further review of additional information received the following sections b4, b5, b6, b7, g3, g4, g5, g7, h2 and h6 have been updated accordingly.In a review of the labeling, it is a known complication that there may be superficial or deep infections for shoulder replacement devices.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.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 patient infection of the shoulder joint devices is most likely due to the patient's underlying conditions.This device is used for treatment, not diagnosis.Section(s): no information has been provided.Asked, not answered: a3, a4, a5, a6.Corrected data: no device evaluation pending.

Event Description

It was reported from the united kingdom that a patient experienced a revision surgery shoulder device due to infection.The patient presented the week before the revision surgery with pus seeping from the operative scar.The implants were removed, and antibiotic balls and an antibiotic cement spacer was inserted.Some of the explanted devices were sent to microbiology for analysis, all devices were disposed of.The revision surgery had no delays.The representative was only able to retrieve the serial numbers, that were appropriately reported.There is no indication or complaint that the devices malfunctioned.No additional information has been provided.This is one of thirteen products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00868, 1038671-2017-00870, 1038671-2017-00871, 1038671-2017-00872, 1038671-2017-00873, 1038671-2017-00874, 1038671-2017-00875, 1038671-2017-00876, 1038671-2017-00877, 1038671-2017-00878, 1038671-2017-00879 and 1038671-2017-00880.

• Brand Name: EQUINOXE REVERSE HUMERAL ADAPTER TRAY
• Type of Device: HUMERAL ADAPTER TRAY
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7129986
• MDR Text Key: 95253363
• Report Number: 1038671-2017-00869
• Device Sequence Number: 1
• Product Code: KWT
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 320-10-00
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR