MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 36MM HUM LINER +2.5; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-36-03
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The revision reported was likely from prothesis wear of the humeral liner from scapular notching and/or an insufficient bond between the glenoid component and bone leading to aseptic (non-infected) loosening.Furthermore, the loosening likely caused the screw fracture due to increased bending moments.However, the cause and/or sequence of events cannot be confirmed from the provided information.D10: (b)(6), a10012 - gps implant kit v2; (b)(6), 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm; (b)(6), 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm; (b)(6), 320-15-05 - eq rev locking screw; (b)(6), 320-31-36 - glenosphere, 36mm; (b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0; (b)(6), 320-36-03 - 145-deg pe 36mm hum liner +2.5; (b)(6), 531-78-20 - shouldr gps hex pins kit; (b)(6), 300-01-09 - equinoxe, humeral stem primary, press fit 9mm; (b)(6), 320-20-00 - eq reverse torque defining screw kit; (b)(6), 531-20-00 - shldr gps rvrs drill kit; (b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm; (b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.
Event or Problem Description
As reported, approximately 1 year and 4 months post the initial left reverse total shoulder arthroplasty, the patient presented with loosening of the glenoid side components.No infection was present.The patient was revised and the surgeon removed the glenoid implants, and packed it with bone graft.The implant was converted to a hemi and the patient will revisit in 3 months to determine when a reverse can be implanted.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.No other patient information/medical history reported.

• Brand Name: 145-DEG PE 36MM HUM LINER +2.5
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21708534
• Report Number: 1038671-2025-01677
• Device Sequence Number: 4656283
• Product Code: KWS
• UDI-Device Identifier: 10885862086624
• UDI-Public: 10885862086624
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K093275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted 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): 03/27/2025

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: 09/06/2026
• Device Catalogue Number: 320-36-03
• 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: 06/23/2023
• Initial Report FDA Received Date: 03/27/2025
• Date Device Manufactured: 09/09/2021
• 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: Female