MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE REVERSE 42MM GLENOSPHERE

Model Number 320-01-42

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 09/18/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant medical devices: 0+ 42mm humeral liner (cat# 320-42-00 / sn# (b)(4)).Equinoxe reverse tray adapter plate tray +0 (cat# 320-10-00 / sn# (b)(4)).

Event Description

It was reported that the surgeon revised this shoulder due to instability.The patient was stable as they left the operating room.

Event Description

It was reported that the surgeon revised a patient due to instability.The patient is moderately active but there were no habits that could have caused the instability.The patient was stable leaving the or.Devices not returning according to hospital policy.

Manufacturer Narrative

Section h10: (d4) expiration date: 07-nov-2021 (d6) if implanted, give date: (b)(6) 2017 (h3) as reported the 69 y/o patient who weighs 98 lbs., experienced a revision of the shoulder.The tibial insert was revised due to pain and instability approximately 10 years after total shoulder replacement.The patient was satisfactory upon leaving the or.Devices will not be returned for evaluation due to hospital policy.Upon review of all available information, there is no evidence to suggest that a design or manufacturing issue caused or contributed to this event.The reported revision was likely the result of an aging implanted device and underlying patient factors, which led to instability of the joint.(h4) device manufacture date: 09-nov-2016 (h6) evaluation codes: 1924, 2993.Section h11: *the following sections have corrected information: (b5) description summary: it was reported that the surgeon revised a patient due to instability.The patient is moderately active but there were no habits that could have caused the instability.The patient was stable leaving the or.Devices not returning according to hospital policy.(d4) serial number: (b)(4), *no information provided in the following section(s): a3, a4, a5, b6, b7, g8, h7,.

• Brand Name: EQUINOXE
• Type of Device: EQUINOXE REVERSE 42MM GLENOSPHERE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9156090
• MDR Text Key: 161790253
• Report Number: 1038671-2019-00483
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086396
• UDI-Public: 10885862086396
• 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: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2021
• Device Model Number: 320-01-42
• Device Catalogue Number: 320-01-42
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR