MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM

Catalog Number 320-20-34

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2016.Revision due to fracture of the glenosphere.

Manufacturer Narrative

Corrections made in the following section(s): patient identifier.Serial number, expiration date, unique identifier (udi) #.Date received by manufacturer ¿ date on supplemental submission should have been 05-aug-2019, pma/510(k)number.

Manufacturer Narrative

The revision reported was likely the result of fracture of the glenosphere.However, this cannot be confirmed as the devices were not available for evaluation, and no further information was provided.¿problems, complication, reoperations, and revisions in reverse total shoulder arthroplasty: a systemic review¿ [1] and ¿comparison of complication types and rates associated with anatomic and reverse total shoulder arthroplasty¿ [2] were reviewed.Between the two studies, approximately 4,940 rtsas were reviewed.Of these, none reported fracture of the glenosphere component.[1] m.A.Zumstein, m.Pinedo, j.Old, and p.Boileau, ¿problems, complications, reoperations, and revisions in reverse total shoulder arthroplasty: a systematic review,¿ journal of shoulder and elbow surgery, pp.146¿157, 2011.[2] s.Parada, r.Friedman, j.D.Zuckerman, t.Wright, p.H.Flurin, and c.P.Roche, ¿comparison of complication types and rates associated with anatomic and reverse total shoulder arthroplasty.¿.

• Brand Name: EQUINOXE
• Type of Device: EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8281994
• MDR Text Key: 134231080
• Report Number: 1038671-2019-00028
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/28/2021
• Device Catalogue Number: 320-20-34
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR