MAUDE Adverse Event Report: EXACTECH, INC. SMALL SUPERIOR/POSTERIOR AUG GLENOID PLATE,LEFT; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	320-35-07
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation: concomitant medical products: concomitant device(s): 300-01-09 - equinoxe, humeral stem primary, press fit 9mm; 320-36-00 - 36mm humeral liner +0 unconstrained; 320-10-00 - equinoxe reverse tray adapter plate tray +0; 320-35-07 - small superior/posterior aug glenoid plate,left.
Event or Problem Description
As reported, approximately 2 years post op the tsa, this (b)(6) female patient was revised to a standard reverse due to aseptic glenoid loosening.Baseplate loosened which was followed by stem loosening.The case report form indicates this event is possibly related to devices and/or procedure.This event report was received through clinical data collection activities.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported may have been the result of an insufficient bond between the implants and the bone, patient-related conditions, or a combination of these possibilities, which led to aseptic (non-infected) glenoid and humeral loosening.However, this cannot be confirmed as the devices were not returned for evaluation and pre-revision x-rays were unable to be obtained.Section h11: *the following sections have corrected information: (d1) brand name: small superior/posterior aug glenoid plate,left (d2b) common device name: prosthesis, shoulder, non-constrained, metal/polymer cemented (d4) catalog number: 320-35-07, serial number: (b)(6), expiration date: 29-sep-2029, unique identifier (udi) #: 10885862534910 (d10) concomitant device(s): 320-20-18, (b)(6) - eq rev compress screw lck cap kit, 4.5 x 18mm 320-20-30, (b)(6) - eq rev compress screw lck cap kit, 4.5 x 30mm 320-20-34, (b)(6)- eq rev compress screw lck cap kit, 4.5 x 34mm 320-20-34, (b)(6)- eq rev compress screw lck cap kit, 4.5 x 34mm.(h4) device manufacture date: 01-oct-2019 (h6) component code: 4755, part/component/sub-assembly term not applicable.

• Brand Name: SMALL SUPERIOR/POSTERIOR AUG GLENOID PLATE,LEFT
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 14498404
• Report Number: 1038671-2022-00603
• Device Sequence Number: 5645712
• Product Code: KWT
• UDI-Device Identifier: 10885862534910
• UDI-Public: 10885862534910
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2022

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: 320-35-07
• Device Catalogue Number: 320-35-07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White