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

Catalog Number 320-46-10

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problems Joint Disorder (2373); No Information (3190)

Event Date 06/01/2017

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2016.Revision due to humeral liner disassociation.

Manufacturer Narrative

The complaint products were received for analysis.The condition of humeral liner dissociation was confirmed.Visual evaluation condition/findings (conducted with a 7x or 10x optical) the scratches on the outside surface of the glenosphere were likely the result of the glenosphere articulating against the reverse adapter tray after the liner dissociated from the tray.The scratches on the outside surface of the glenosphere were likely the result of the glenosphere articulating against the reverse adapter tray after the liner dissociated from the tray.Excessive wear of the humeral liner appears consistent with disassembling from the adapter tray and contacting the reverse adapter tray as the patient moved.Since the liner was free in the joint space, the deformation may have come from bony impingement as well.The locking button was most likely deformed due to the humeral liner disassociating from the tray, allowing it to articulate.The threads of the torque defining screw seem to be unremarkable and consistent with being implanted.The frequency of occurrence ranking is very low; therefore, this does not appear to be a design issue.The company is not aware of receiving any other complaint reports involving another part from these manufacturing lots of (b)(4) (glenosphere), (b)(4) (adapter tray) and (b)(4) (humeral liner) pieces that have been in the field since 2010, 2015 and 2012, respectively.A review of the device history record showed that the reverse adapter tray and humeral liner were accepted with conformance to the device requirements.Therefore, the issue does not appear to be manufacturing related.The revision reported was likely the result of not fully assembling the humeral liner to the adapter tray at the time of the original surgery, which led to disassociation of the humeral liner from the adapter tray.Additionally, the severe wear on the sides of the humeral liner indicate that the disassociation may have been caused by bony impingement, however this cannot be confirmed.There is no patient medical information provided; therefore, it is not possible to assess the patient risk/clinical factors.This device is used for treatment not diagnosis.

Event Description

It was reported that a mid 50-60 yo average build male patient experienced a shouldger revision due to humeral liner disassociation on (b)(6) 2017.Initial surgery was (b)(6) 2016.The patient felt uncomfortable but did not have a lot of pain, stated, "didn't feel right".There was no indication that the humeral liner was not fully seated immediately following the original surgery.The revision surgery went very well.The patient is doing well post-op.There is no additional information provided on the event or patient.This is one of four products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00370, 1038671-2017-00371, and 1038671-2017-00373.

• Brand Name: EQUINOXE REVERSE HUMERAL LINER, CONSTRAINED
• Type of Device: HUMERAL LINER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• MDR Report Key: 6642896
• MDR Text Key: 77624993
• Report Number: 1038671-2017-00372
• 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: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/05/2017
• Device Catalogue Number: 320-46-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Date Manufacturer Received: 05/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention