MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE REVERSE 42MM HUMERAL CONST LINER +0

Catalog Number 320-42-10

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 06/03/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant medical products: (cn: 320-01-42, sn: (b)(4)) glenoshphere 42mm, (cn: 320-10-00, sn; (b)(4)) reverse humeral adapter tray +0, (cn: 320-15-05, sn; (b)(4)) glenosphere locking screw, (cn: 320-20-00, sn: (b)(4)) torque defining screw kit.

Event Description

Primary surgery: (b)(6) 2013.Original reverse shoulder arthroplasty was performed on this male patient¿s left shoulder.The surgeon opened the joint in standard fashion.Once the surgeon got in to the shoulder joint the surgeon realized that the poly had broken off of the adapter tray.The surgeon then proceeded to remove everything except the stem, baseplate and screws.The surgeon then trailed different options on the glenoid and humeral sides.The surgeon trailed until he made the shoulder stable.The surgeon then told me to open the implants the surgeon selected.The surgeon implanted the components and reduced the shoulder.The patient was stable when they left the operating room.

Event Description

During the procedure, the joint was opened in standard fashion.Once he got in to the shoulder joint the surgeon realized that the poly had broken off of the adapter tray.He then proceeded to remove everything except the stem, baseplate and screws.He then trialed different options on the glenoid and humeral sides.He trialed until he made the shoulder stable.He then told me to open the implants he selected.He implanted the components and reduced the shoulder.The patient was stable when they left the or reason for revision was not given.

Manufacturer Narrative

Section h10: (b2) outcomes attributed to adverse event: added check for hospitalization - initial or prolonged (d4) unique identifier (udi) #: (b)(4).(h3) the humeral liner disassociation reported may have been the result of either incomplete seating of the humeral liner during implantation, forceful contact between the humeral liner and bone (impingement/scapular notching), or extreme wear of the humeral liner, which led to the humeral liner disassociating from the humeral tray.However, this cannot be confirmed as the devices were not returned for evaluation and no x-rays/images were provided.(h6) evaluation codes: 1924, 2923 section h11: *the following sections have corrected information: (b5) describe event or problem: during the procedure, the joint was opened in standard fashion.Once he got in to the shoulder joint the surgeon realized that the poly had broken off of the adapter tray.He then proceeded to remove everything except the stem, baseplate and screws.He then trialed different options on the glenoid and humeral sides.He trialed until he made the shoulder stable.He then told me to open the implants he selected.He implanted the components and reduced the shoulder.The patient was stable when they left the or reason for revision was not given.No information provided in the following section(s): a5, b6, b7, g8, h7, h9.

• Brand Name: EQUINOXE
• Type of Device: EQUINOXE REVERSE 42MM HUMERAL CONST LINER +0
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8755039
• MDR Text Key: 149849277
• Report Number: 1038671-2019-00346
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/01/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2017
• Device Catalogue Number: 320-42-10
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/13/2019
• Initial Date FDA Received: 07/02/2019
• Supplement Dates Manufacturer Received: 04/28/2020
• Supplement Dates FDA Received: 05/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR