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	Insufficient Information (4580)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: 321-52-07 - 3.2mm drill bit sterile (b)(6), 300-30-10 - equinoxe preserve stem 10mm (b)(6), 320-31-36 - glenosphere, 36mm (b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0 (b)(6), 321-52-10 - 3.2mm k-wire, thd, short 2 k-wires per pack (b)(6), 321-52-09 - 3.2mm k-wire, trocar tip (b)(6), 320-35-01 - small glenoid plate (b)(6), 320-36-00 - 145-deg pe 36mm hum liner +0 (b)(6), 320-20-00 - eq reverse torque defining screw kit (b)(6), 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm (b)(6), 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm (b)(6), 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm (b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm (b)(6).The revision reported was likely the result of disassembly of the glenosphere locking screw from the glenoid baseplate.The deformation observed on the explanted locking screw could have resulted from abnormal articulation as the screw backed out over time or incomplete seating at the time of implantation.A secondary finding of prosthesis wear likely resulted from a combination of impingement of the liner with the scapula and abnormal articulation following the locking screw disassembly.However, disassembly and the series of events cannot be confirmed as the devices were not returned for evaluation and no radiographs were provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that this patient's left knee was revised.Sometime since that surgery the surgeon discovered that the glenosphere had dissociated from the baseplate which meant the locking screw backed out.It appeared that the glenosphere seemed to still be articulating with the liner, but obviously needed to be revised.The surgeon discovered the patient's glenosphere and locking screw had backed out and dissociated from the baseplate, requiring revision surgery.The surgeon was able to remove the old poly, glenosphere and locking screw.From there, tensioning required a larger tray, so he removed the original torque screw and tray and implanted larger 40mm components and a 5mm tray.Patient was last known to be in stable condition following the event.

• 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 INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 23291893
• Report Number: 1038671-2025-03109
• Device Sequence Number: 10037511
• Product Code: KWT
• UDI-Device Identifier: 10885862086617
• UDI-Public: 10885862086617
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2024
• 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): 10/14/2025

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 Catalogue Number: 320-36-00
• 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: 10/01/2025
• Initial Report FDA Received Date: 10/15/2025
• Date Device Manufactured: 12/01/2021
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male