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

Model Number	42MM 2.5MM CONSTRAINED LINER
Medical Device Problem Codes	Unstable (1667); Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Laxity (4526)
Date of Event	06/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, on (b)(6) surgeon brought a male patient aged 63 back for a revision surgery.The index procedure was done sometime in 2018.The patient presented with pain and feeling unstable.The 42mm 2.5mm constrained implant was disengaged and floating loosely in the joint.Sales rep was unable to get a serial number.Surgeon also removed the 0mm tray.The tray was replaced with a 5mm tray and the liner was replaced with a +0 constrained liner.The patient appear to do well with the surgery.Image received.The devices are not available for evaluation.
Additional Manufacturer Narrative
Section d6a: implant date - patient original tsa implant was done in 2018 - not exact date available.Section d10: concomitant product: eq rvs hum adptr plt +0 (cat# 320-110-00 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1/d2a/d2b, d4, d6a/d6b, h4, g3/g4, h6 mdr section codes updated/corrected: a, b, d, e.The revision reported may have been due to disassembly, prosthesis wear, migration, and/or instability.However, the reported disassembly, migration, and instability could not be confirmed.Additionally, potential contributions of user and patient-related considerations, 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 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17216363
• Report Number: 1038671-2023-01488
• Device Sequence Number: 6232696
• Product Code: KWT
• UDI-Device Identifier: 10885862086723
• UDI-Public: 10885862086723
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/20/2020
• Device Model Number: 42MM 2.5MM CONSTRAINED LINER
• 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: 06/08/2023
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2015
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male