MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 40MM HUM LINER +0; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	320-40-00
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Osteolysis (2377); Swelling/ Edema (4577); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that approximately 17 months after a left total shoulder replacement procedure, the patient has experienced prosthesis wear.The patient has not yet undergone a revision procedure.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
1038671-2025-00013 1038671-2025-00096 d10: a222569 320-10-05 - equinoxe reverse tray adapter plate tray +5 a501238 320-20-00 - eq reverse torque defining screw kit the product associated with the reported event is within the scope of recall z-1420-2024; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2025-00013, 1038671-2025-00096 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.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, loosening, loss of range of motion, or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices remain implanted and radiographs were not provided.H1: corrected.H6: corrected health effect, medical device, component, and investigation clinical codes.H10 related report numbers: 1038671-2025-02141, 1038671-2025-00096, 1038671-2025-00013, 1038671-2025-02178.

• Brand Name: 145-DEG PE 40MM HUM LINER +0
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21085843
• Report Number: 1038671-2025-00099
• Device Sequence Number: 15550108
• Product Code: PHX
• UDI-Device Identifier: 10885862535030
• UDI-Public: 10885862535030
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/14/2025
• Device Catalogue Number: 320-40-00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 05/28/2025
• Date Device Manufactured: 09/16/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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.
• Patient Sex: Unknown