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 Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant device(s): 300-30-08 - equinoxe preserve stem 8mm: (b)(6).320-08-42 - glenosphere exp 42mm +4mm offset: (b)(6).320-10-00 - equinoxe reverse tray adapter plate tray +0: (b)(6).320-15-07 - sup/post aug plate, l rs glenoid baseplate: (b)(6).315-35-00 - glnd kwire: (b)(6).315-35-00 - glnd kwire: (b)(6).320-15-05 - eq rev locking screw: (b)(6).320-20-00 - eq reverse torque defining screw kit: (b)(6).320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm: (b)(6).320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm: (b)(6).320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm: (b)(6).320-20-46 - eq rev compress screw lck cap kit, 4.5 x 46mm: (b)(6).531-55-88 - ergo gps 3.2mm drill kit sterile: (b)(6).
Event or Problem Description
Approximately 1 year(s), 8 month(s) and 29 day(s) post-operative of a left tsa, it was reported via clinical study that the patient experienced disassociation of polyethylene.Poly popped out without real trauma.Decreasing motion over last several months.The patient underwent a standard reverse revision, and the outcome of this event is considered resolved.The clinical report indicates that this event is definitely related to the device(s) and possibly related to the procedure.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: g3, h6, h11 mdr section codes updated/corrected: b, c, d, g the revision was likely the result of disassembly between the humeral liner and humeral tray and loss of range of motion as reported.However, these failures cannot be confirmed and potential contributions from patient conditions, an unreported traumatic event, incomplete seating of the humeral liner during implantation, forceful contact between the liner and glenoid bone (scapular notching), or a combination of the above 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: 20130951
• Report Number: 1038671-2024-03241
• Device Sequence Number: 14250071
• Product Code: KWT
• UDI-Device Identifier: 10885862086723
• UDI-Public: 10885862086723
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2025

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: 12/24/2024
• 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: 08/16/2024
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2019
• 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 H11.
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 137 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White