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

Catalog Number 320-15-05

Device Problems Disassembly (1168); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001); Migration (4003)

Patient Problems Pain (1994); Joint Disorder (2373); No Code Available (3191)

Event Date 07/25/2017

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2011.Revision of shoulder components due to screw disassembly.

Manufacturer Narrative

This device is used for treatment not diagnosis.No information, asked not provided.Corrected data: section b5: describe event or problem.

Event Description

It was reported that a female patient received a "reverse total shoulder replacement was originally performed approximately 6 years prior by this same surgeon.The patient did well with rehab and recovery with excellent range of motion, strength, pain relief and function.The patient related to the doctor that the shoulder started feeling "funny" about 6 weeks prior to her office visit.A week prior, she was transferring wet laundry from the washing machine to the dryer when the shoulder "popped" and she had pain in the shoulder.The doctor noted decreased rom, painful motion and a noticeable "clicking feel" during manipulation.Fluoroscopy and x-rays at the time revealed the glenosphere sitting proud on the glenoid baseplate and the head of the glenosphere locking screw was visible.Revision of the reverse shoulder was undertaken by the same doctor.The glenosphere locking screw was found to be intact but completely disengaged from the glenoid base plate.The glenosphere, glenosphere locking screw and worn humeral liner were removed.A new locking screw was trialed to assure the threads in the baseplate were sound and could be reused.A new 38mm +4 glenosphere was installed with the new glenosphere locking screw with particular attention to screw locking.A new 38mm +2.5 humeral liner was assembled on the existing humeral tray, the shoulder was reduced, rom and stability were tested with satisfactory results.This is one of three products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00539, 1038671-2017-00540.

• Brand Name: EQUINOXE REVERSE GLENOSPHERE LOCKING SCREW
• Type of Device: SCREW
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 6770339
• MDR Text Key: 81923168
• Report Number: 1038671-2017-00541
• 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
• Report Date: 05/27/2019

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: Physician
• Device Expiration Date: 12/11/2021
• Device Catalogue Number: 320-15-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/26/2017
• Initial Date FDA Received: 08/07/2017
• Supplement Dates Manufacturer Received: 05/20/2019
• Supplement Dates FDA Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR