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); Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Joint Dislocation (2374); Metal Related Pathology (4530)
Date of Event	09/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a male patient, previous right shoulder implanted in (b)(6) 2023, underwent a revision procedure in (b)(6) 2024, approximately 1 year 8 months post the past procedure.The patient came back with another dislocation from a previous rtsa.He said he was changing a tire on a tractor and pushing very hard, when his shoulder popped out.The surgeon believed the poly disassociated and viewed imaging with the rep.The tray was articulating with the sphere so it was believed this to be the case.During the procedure, upon exposure, the poly was disassociated and lived posterior to the humerus.It was removed.The tray had wear and metallosis was present.It was recommended that both the tray and sphere be exchanged, but the surgeon did not want to exchange the sphere due to fear of "doing too much".The rep recommended to feel the sphere and make sure there were no sharp, worn, etc surfaces that would compromise a new poly and cause any further wear.The surgeon said it felt smooth and fine to him, and he did not exchange the sphere even after recommendation.The tray was exchanged, upsized, and implanted with a new poly.There was breakage of device reported, but no parts or pieces fell into the wound site.There were no surgical delays during the procedure.The patient was last known to be in stable condition following the event.X-rays were provided.The explanted devices are not available for evaluation.The hospital does not allow the reps to take the implants.Device images were provided.No further information.
Additional Manufacturer Narrative
D10: concomitants: 7026798 300-01-15 - equinoxe, humeral stem primary, press fit 15mm; a203853 320-08-42 - glenosphere exp 42mm +4mm offset; a291065 320-15-05 - eq rev locking screw; a256632 320-20-00 - eq reverse torque defining screw kit.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: a, b, c, d, g.The revision reported was likely the result of dislocation that may have caused disassembly between the humeral liner and tray, resulting in additional wear of the humeral liner and tray.However, the reported prosthesis wear of the tray, dislocation, and sequence of events could not be confirmed from the provided information.Potential contributions of user and patient-related considerations to the event, an unreported traumatic event, incomplete seating of the humeral liner during implantation, forceful contact between the liner and glenoid bone (scapular notching), or a combination of the above to the disassembly of the humeral liner could not be assessed as the devices were not available for evaluation.Should additional relevant information be obtained, a follow-up mdr will be submitted 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 20164959
• Report Number: 1038671-2024-03347
• Device Sequence Number: 15262573
• Product Code: KWT
• UDI-Device Identifier: 10885862086723
• UDI-Public: 10885862086723
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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,Followup
• Report Date (Section B): 10/17/2025

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: 01/17/2024
• 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: 09/04/2024
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 09/07/2024
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2019
• 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: Required Intervention
• Patient Sex: Male