MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 42MM HUM LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-42-00
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial total shoulder arthroplasty on the right side.Subsequently, the patient was revised due to poly disassociation.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
D10: 320-06-42 - glenosphere 42mm: (b)(6).320-20-00 - eq rev torque defining screw kit: (b)(6).320-15-05 - eq rev locking screw: (b)(6).319-01-32 - steinmann pin sterile 3.2mm x 178mm: (b)(6).320-15-06 - rs glenoid plate ext cag +10mm cage peg: (b)(6).320-20-26 - eq rev comp scr lck cap kit, 4.5 x 26mm: (b)(6).320-20-42 - eq rev comp scr lck cap kit, 4.5 x 42mm: (b)(6).320-20-42 - eq rev comp scrlck cap kit, 4.5 x 42mm: (b)(6).320-20-42 - eq rev comp scr lck cap kit, 4.5 x 42mm: (b)(6).320-20-42 - eq rev comp scr lck cap kit, 4.5 x 42mm: (b)(6).320-20-42 - eq rev comp scr lck cap kit, 4.5 x 42mm: (b)(6).321-52-07 - 3.2mm drill bit sterile: (b)(6).The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was 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 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: geoff gannon ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 24009060
• Report Number: 1038671-2026-00022
• Device Sequence Number: 9315503
• Product Code: KWT
• UDI-Device Identifier: 10885862086693
• UDI-Public: 10885862086693
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 01/08/2026

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 Catalogue Number: 320-42-00
• 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: 12/19/2025
• Initial Report FDA Received Date: 01/08/2026
• Date Device Manufactured: 10/03/2023
• 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: Hospitalization
• Patient Sex: Unknown