MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; 36MM GLEN TRL

Model Number	320-01-36
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical device(s): reverse tray (cat# 320-10-00 / sn# (b)(4)).Humeral liner (cat# 320-36-13 / sn# (b)(4)).Torque defining screw kit (cat# 320-20-00 / sn# (b)(4)).Reverse tray adapter plate (cat# 320-10-10 / sn# (b)(4)).Torgue defining screw kit (cat# 320-20-00 / sn# (b)(4)).Rev locking screw (cat# 320-15-05 / sn# (b)(4)).Compress lck cap (cat# 320-20-18 / sn# (b)(4)).Compress lck cap (cat# 320-20-26 / sn# (b)(4)).Compress lck cap (cat# 320-20-22 / sn# (b)(4)).Compress lck cap (cat# 320-20-18 / sn# (b)(4)).Compress lck cap (cat# 320-20-30 / sn# (b)(4)).
Event or Problem Description
It was reported that the patient had gone through a shoulder reverse on the (b)(6) of (b)(6) 2019, due to baseplate loosening and instability on the glenoid the shoulder was revised.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of an insufficient bond between the implant and the bone, patient¿s bone quality, or a combination of the two, which led to aseptic (non-infected) loosening of the glenoid baseplate and instability.However, this cannot be confirmed as the devices were not available for evaluation.(h4) device manufacture date: 08-feb-2019.
Additional Manufacturer Narrative
Section h10: (g5) pma/510(k)number: k063569.Section h11: *the following sections have corrected information: (d4) catalog number: 320-15-01, serial number: (b)(6), expiration date: 05-feb-2029, unique identifier (udi) #: (b)(4).(d11) concomitant device(s): ** added glenosphere** 36mm glenosphere (cat# 320-01-36 / sn#: b)(6)).Reverse tray (cat# 320-10-00 / sn#: b)(6)).Humeral liner (cat# 320-36-13 / sn#: b)(6)).Torque defining screw kit (cat# 320-20-00 / sn#: b)(6)).Reverse tray adapter plate (cat# 320-10-10 / sn#: b)(6)).Torgue defining screw kit (cat# 320-20-00 / sn#: b)(6)).Rev locking screw (cat# 320-15-05 / sn#: b)(6)).Compress lck cap (cat# 320-20-18 / sn#: b)(6)).Compress lck cap (cat# 320-20-26 / sn#: b)(6)).Compress lck cap (cat# 320-20-22 / sn#: b)(6)).Compress lck cap (cat# 320-20-18 / sn#: b)(6)).Compress lck cap (cat# 320-20-30 / sn#: b)(6)).

• Brand Name: EQUINOXE
• Common Device Name: 36MM GLEN TRL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9134811
• Report Number: 1038671-2019-00474
• Device Sequence Number: 3587256
• Product Code: KWT
• UDI-Device Identifier: 10885862086372
• UDI-Public: 10885862086372
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2020

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
• Operator of Device: Health Professional
• Device Model Number: 320-01-36
• Device Catalogue Number: 320-15-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 02/06/2020; 03/25/2020
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 02/06/2020; 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention