MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE GLENOSPHERE

Catalog Number 320-01-46

Device Problems Disassembly (1168); Material Deformation (2976)

Patient Problems Failure of Implant (1924); Joint Disorder (2373)

Event Date 07/06/2017

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2015.Revision due to poly disassembly.

Manufacturer Narrative

The complaint products were received for analysis.The user experience of poly disassembly was confirmed.Visual evaluation condition/findings (conducted with a 7x or 10x optical).The scratches and deformations on the superior surface of the humeral tray appear to be consistent with a combination of using a metal tool to remove the components during the revision surgery and articulating with the glenosphere after the disassociation of the humeral liner.The scratches suggest that the glenosphere likely cantilevered on the edge of the humeral tray.Scratches on the outside of the glenosphere were likely the result of the glenosphere articulating against the adapter tray after the liner dissociated from the tray.The deformation on the underside of the humeral liner appears consistent with being free in the joint space and contacting the adapter tray and glenosphere.The threads of the locking screw appears to be unremarkable and consistent with being implanted.The frequency of occurrence ranking scale is very low; therefore, this does not appear to be design-related.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), (b)(4) (humeral liner) and (b)(4) (locking screw) pieces that have been in the field since 2015.Manufacturing data for the humeral liner could not be reviewed because the manufacturing lot/serial information was not provided.A review of the device history record showed that the reverse adapter tray was accepted with conformance to the device requirements.Therefore, this 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.There is no patient medical information provided; therefore, it is not possible to assess the patient risk/clinical factors.It is found in a review of the labeling -device specific risks include: fracture, migration, loosening, subluxation, or dislocation of the prosthesis or any of its components, any of which may require a second surgical intervention or revision.It is also noted that excessive wear of the implant components secondary to impingement of components or damage of articular surfaces.Also, as part of the pre-operative assessment, the surgeon must ensure that no biological, biomechanical, or other factors exist that might adversely affect the surgery and/or the postoperative period.This device is used for treatment not diagnosis.

Event Description

It was reported that a patient experienced a shoulder revision surgery due to poly disassembly.The poly appeared to be disengaged from the humeral tray, it was located in the anterior joint capsule.The patient did well and the case went "extremely well".The surgery for the reverse shoulder was (b)(6) 2015.There is no additional information about the event or the patient.This is one of four products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00512, 1038671-2017-00514 and 1038671-2017-00515.

• Brand Name: EQUINOXE REVERSE GLENOSPHERE
• Type of Device: GLENOSPHERE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 6744276
• MDR Text Key: 81052150
• Report Number: 1038671-2017-00513
• 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: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 320-01-46
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Was the Report Sent to FDA?: No
• 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
• Patient Age: 64 YR