MAUDE Adverse Event Report: Exactech, Inc. 145-DEG PE 42MM HUM LINER +2.5; Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Catalog Number	320-42-03
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 7 years and 7 months post the initial right total shoulder arthroplasty, the patient was revised due to the poly disengaging and the shoulder dislocating.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.

• Brand Name: 145-DEG PE 42MM 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 66th ct; gainesville FL 32653
• Manufacturer Contact: julia goldberg ; 2320 nw 66th ct; gainesville, FL 32653 ; +1 (352) 377-1140
• MDR Report Key: 50945327
• Report Number: 1038671-2026-01252
• Device Sequence Number: 9624355
• Product Code: KWT
• UDI-Device Identifier: 10885862086709
• UDI-Public: 10885862086709
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 10/06/2019
• Device Catalogue Number: 320-42-03
• 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: 11/08/2022
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 10/09/2014
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male