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

Catalog Number 320-10-00

Device Problems Contamination (1120); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Joint Disorder (2373); Joint Dislocation (2374); No Code Available (3191)

Event Date 08/16/2017

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Revision due to dislocation and infection.Implants were removed and antibiotic balls were placed.Stage 2 revision planned after infection clears up.

Manufacturer Narrative

After further review of additional information received the following sections b4, b5, b6, b7, g3, g4, g5, g7, h2, h4 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.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.There are device specific risks of fracture, migration, loosening, subluxation, or dislocation of the prothesis or any of its components, and any of which may require a second surgical intervention or revision.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 most likely cause of the revision for should device dislocation and infection are the patients underlying conditions.This device is used for treatment, not diagnosis.No information has been provided.Asked, not answered: a4, a5, a6, d6.Corrected data: no device evaluation pending.

Event Description

It was reported from the united kingdom that a patient experienced a revision surgery due to dislocation and infection.The shoulder was dislocating anteriorly, the intention was to replace the liner and do a wash out.However, upon opening the patient it was apparent that the infection was far more significant than first anticipated, it was decided to remove the whole fracture reverse shoulder and put in the antibiotic balls.It was reported that the patient will be scheduled for stage 2 of the revision after the infection is cleared, there is no information if this has occurred.The patient is reported as medically well.The hospital would not release the implants and they were disposed of.There is no complaint or allegation of device malfunction.Information was requested, and no additional information was provided.This is one of ten products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00632, 1038671-2017-00633, 1038671-2017-00634, 1038671-2017-00635, 1038671-2017-00636, 1038671-2017-00637, 1038671-2017-00638, 1038671-2017-00639 and 1038671-2017-00641.

• 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: 6821103
• MDR Text Key: 83663429
• Report Number: 1038671-2017-00640
• 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: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• 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: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR