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

Catalog Number 320-38-03

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

Patient Problems Joint Dislocation (2374); No Code Available (3191)

Event Date 12/07/2017

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Revision due to dislocation.

Manufacturer Narrative

After further review of additional information received the following sections b4, b5, b6, b7, d4.Expiration date, g3, g4, g5, g7, h2, h4 and h6 have been updated accordingly.In a review of the labeling it is a known complication that a patient's age, weight, or activity level would cause the surgeon to expect early failure of the system.Device specific risks that fracture, migration, loosening, subluxation, or dislocation of the prothesis or any of its components, any of which may require a second surgical intervention or revision.Revisions or surgical interventions are a known complication found in joint replacements.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 dislocation of the shoulder joint devices is most likely due to the patient's underlying conditions.This device is used for treatment, not diagnosis.60+ yo, as reported.Section(s): no information has been provided.Asked, not answered: 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, of shoulder devices due to a dislocation.The shoulder was dislocating anteriorly.The glenosphere was removed and a large piece of bone from the greater tuberosity was found behind it.The surgeon cleared soft tissue around the glenoid and changed the 38mm glenosphere and +2.5mm liner to a 42mm glenosphere and +2.5mm liner.The implants will not be released from the hospital."the patient was stable upon leaving the or and has been stable since surgery".There is no indication or complaint that the device malfunctioned.No additional information has been provided.This is one of three products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00905 and 1038671-2017-00906.

• Brand Name: EQUINOXE REVERSE HUMERAL LINER
• Type of Device: LINER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7137775
• MDR Text Key: 95478672
• Report Number: 1038671-2017-00904
• 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: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/26/2020
• Device Catalogue Number: 320-38-03
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR