MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 36MM HUM LINER +0; Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Catalog Number	320-36-00
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a right shoulder replacement procedure.Subsequently, the patient experienced recurrent shoulder dislocations, and the glenosphere became dissociated.As a result, all implanted components, with the exception of the stem, were removed.Photographs show one of the compression screws had fractured and that the poly was worn.X-rays were also provided and showed evidence of migration due to the disassembly.The patient was last known to be in stable condition following the event.No further information is available.

• Brand Name: 145-DEG PE 36MM HUM LINER +0
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: julia goldberg ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 25366112
• Report Number: 1038671-2026-00697
• Device Sequence Number: 18603692
• Product Code: KWT
• UDI-Device Identifier: 10885862086617
• UDI-Public: 10885862086617
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2026

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: 12/08/2025
• Device Catalogue Number: 320-36-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Supplement Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 06/02/2026
• Supplement Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2020
• 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
• Patient Age: 72 YR
• Patient Sex: Female