MAUDE Adverse Event Report: EXACTECH, INC. 36MM HUMERAL LINER +2.5MM CONSTRAINED; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-36-13
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Subluxation (4525)
Date of Event	10/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): 300-01-09 - equinoxe, humeral stem primary, press fit 9mm: 6512831.320-10-00 - equinoxe reverse tray adapter plate tray +0: 6569633.320-31-36 - glenosphere, 36mm: 6579696 320-35-01 - small glenoid plate: 6548601/.
Event or Problem Description
As reported by the equinoxe shoulder study, the patient had an initial left tsa on (b)(6)2020.The patient presented on (b)(6) 2020 instability / subluxation.Patient reports ongoing subluxation events, up to 4-5 times per week.The case report form indicates that this event is possibly related to device and/ to procedure.Outcome is resolved on (b)(6) 2021.Symptoms resolved with strengthening and time.No device return anticipated due to being a clinical trial study.Ebi initial surgery attached.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: a, b, c, d, e, f, g.The cause of the patient¿s shoulder subluxation reported cannot be conclusively determined; however, it may be due to soft tissue imbalance, patient anatomy, implant positioning, and/or implant selection.Subluxation is a known risk, as outlined in the ifu.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: 36MM HUMERAL LINER +2.5MM CONSTRAINED
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18477235
• Report Number: 1038671-2024-00049
• Device Sequence Number: 17790617
• Product Code: KWS
• UDI-Device Identifier: 10885862086648
• UDI-Public: 10885862086648
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K093275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2025

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 Expiration Date: 03/25/2024
• Device Catalogue Number: 320-36-13
• 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: 12/02/2023
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2019
• 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
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Race: White