MAUDE Adverse Event Report: EXACTECH, INC. UHMWPE POST AUG GLENOID MEDIUM, RIGHT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	314-02-33
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	02/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitants: 3951230 310-01-44 - equinoxe, humeral head short, 44mm (alpha); 4163684 300-01-13 - equinoxe, humeral stem primary, press fit 13mm; 4177606 300-20-02 - equinox square torque define screw drive kit; 4186010 300-10-15 - equinoxe replicator plate 1.5mm o/s; 3896137 314-02-33 - uhmwpe post aug gleniod medium, right.H3: 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.
Event or Problem Description
It was reported that this patient's right shoulder was revised approximately 8 years 8 months post initial operation.The implants were removed due to a rotator cuff tear.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: d4, g4, h4, h11.The revision reported was likely the result of rotator cuff deterioration and subsequent superior migration of the humeral head resulting in prosthesis wear of the glenoid component.The reason for the rotator cuff failure cannot be conclusively determined but may be related to an underlying patient condition, component sizing or positioning issues, or a combination of the above.The following sections were corrected: d1, d2a, d2b, h6.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d4, h6.Mdr section codes updated/corrected: a.The revision reported was likely the result of rotator cuff deterioration and subsequent superior migration of the humeral head resulting in prosthesis wear of the glenoid component.The reason for the rotator cuff failure cannot be conclusively determined but may be related to an underlying patient condition, component sizing or positioning issues, or a combination of the above.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: UHMWPE POST AUG GLENOID MEDIUM, RIGHT
• 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21627492
• Report Number: 1038671-2025-01594
• Device Sequence Number: 8331391
• Product Code: KWS
• UDI-Device Identifier: 10885862175106
• UDI-Public: 10885862175106
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K103419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2025

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: 03/15/2020
• Device Catalogue Number: 314-02-33
• 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: 02/25/2025
• Supplement Date Received by Manufacturer: 08/27/2025; 12/16/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 09/15/2025; 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2015
• 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: Hospitalization
• Patient Sex: Male