MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 42MM CONST HUM LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-42-13
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)
Date of Event	07/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The male patient presented to surgeon's office in the spring of 2023 with complaints of sudden and then ongoing pain and dissatisfaction with his left reverse tsa.Upon imaging the implants looked mal-positioned and the glenoid looked like it has bone growth from poly wear.The surgeon thought poly wear and osteolysis caused ongoing issues and potential loosening of the implants.The patient was scheduled for revision left reverse tsa.Revision surgery operative notes were provided.Patient left the operating room in stable condition.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
The product associated with the reported event is within the scope of recall z-1423-2024; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.D10: (b)(6) 320-40-13 - 145-deg pe 40mm const hum liner +2.5.(b)(6) 320-10-10 - equinoxe reverse tray adapter plate tray +10.(b)(6) 320-20-00 - eq reverse torque defining screw kit.The revision reported may be due to prosthesis wear, disassembly, loosening, and/or device-device loosening.Prosthesis wear was confirmed on the humeral liner, humeral tray and glenoid baseplate.Additionally, disassembly was confirmed on the humeral liner and humeral tray based on the observed damage/wear pattern.However, the reported glenosphere prosthesis wear, compression screw prosthesis wear, baseplate disassembly, compression screw cap disassembly, loosening, device-device loosening and the sequence of events could not be determined from the reported information.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation.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 CONST 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21920870
• Report Number: 1038671-2025-01914
• Device Sequence Number: 8907654
• Product Code: KWT
• UDI-Device Identifier: 10885862086723
• UDI-Public: 10885862086723
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/28/2025

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 Expiration Date: 04/24/2017
• Device Catalogue Number: 320-42-13
• 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: 07/26/2023
• Initial Report FDA Received Date: 04/28/2025
• Date Device Manufactured: 04/26/2012
• 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; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male