MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 42MM CONST HUM LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-42-13
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle/Tendon Damage (4532); Unspecified Tissue Injury (4559); Insufficient Information (4580)
Date of Event	02/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant device(s): 320-42-13 - equinoxe reverse 42mm humeral const liner +2.5: 5328719.300-30-12 - equinoxe preserve stem 12mm: 5740799.320-02-42 - rs expanded glenosphere 42mm, +4mm offset: 5610461.320-10-00 - equinoxe reverse tray adapter plate tray +0: 6017507.320-15-03 - rs glenoid plate l post aug, 8 deg, left: 6091511.320-15-05 - eq rev locking screw: 6152805.320-20-00 - eq reverse torque defining screw kit: 6115599.320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm: 5673242.320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm: 5923622.320-20-42 - eq rev compress screw lck cap kit, 4.5 x 42mm: 5927194.321-20-00 - equinoxe reverse shoulder drill kit: 6114925.
Event or Problem Description
Approximately 2 month(s) and 28 day(s) post-operative of a left tsa, the patient presented with disassociation of other component.Patient suffered acute injury in late 2019.The patient underwent standard reverse with preserve stem revision surgery and the outcome of this event is considered resolved.The clinical report indicates that this event is possibly related to the device(s) and unlikely related to the procedure.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that the patient underwent an initial total shoulder replacement on the left side with exactech devices.Subsequently, the patient presented with disassociation of other component.Patient suffered acute injury in late 2019.As a result, approximately 3 month(s) after initial implantation, the patient underwent standard reverse with preserve stem revision surgery and the outcome of this event is considered resolved.The clinical report indicates that this event is possibly related to the device(s) and unlikely related to the procedure.No further impact to the patient was reported.No other information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, d4, g2, g3, g4, h4, h6, h11.Mdr section codes updated/corrected: b, c, d, e, g.The revision reported was likely the result of disassembly between the humeral liner and humeral tray after an acute injury.However, this cannot be confirmed from the information provided and potential contributions from patient conditions to the reported disassembly of the humeral liner cannot be determined as the devices were not returned for evaluation and images/radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: 145-DEG PE 42MM CONST HUM LINER +2.5
• 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; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20034945
• Report Number: 1038671-2024-02983
• Device Sequence Number: 11521838
• Product Code: KWT
• UDI-Device Identifier: 10885862086723
• UDI-Public: 10885862086723
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2025

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: 03/13/2023
• Device Catalogue Number: 320-42-13
• 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: 08/04/2024
• Supplement Date Received by Manufacturer: 08/11/2025; 09/16/2025
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 08/11/2025; 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2018
• 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 H11
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Race: White