MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE GLENOID, PEGGED ALPHA, SMALL; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	314-02-02
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	01/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial right total shoulder arthroplasty at a private hospital in france on an unknown date.The patient was revised due to rotator cuff failure and the implants were removed to eliminate the chance of infection.A spacer was implanted to reduce the risk of infection and allow for planning of the glenoid for second stage revision.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of rotator cuff failure.Proximal positioning of the humeral head relative to the glenoid, which is consistent with rotator cuff failure, can be observed in the provided radiographs.Although the reason for the rotator cuff failure cannot be confirmed, it is likely due to natural degradation of the tendon over time.The observed damage on the glenoid component may have been due to over 9 years of use and/or superior articulation with the humeral head secondary to the rotator cuff failure and subsequent migration of the humeral component.However, this cannot be confirmed because the component was not returned for evaluation.D10: 300-01-13, equinoxe, humeral stem primary, press fit 13mm.300-10-15, equinoxe replicator plate 1.5mm o/s.310-01-47, equinoxe, humeral head short, 47mm (beta).300-20-02, equinox square torque define screw drive kit.

• Brand Name: EQUINOXE GLENOID, PEGGED ALPHA, SMALL
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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 ; 3523771140
• MDR Report Key: 22061945
• Report Number: 1038671-2025-02108
• Device Sequence Number: 20951948
• Product Code: HSD
• UDI-Device Identifier: 10885862084477
• UDI-Public: 10885862084477
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2025

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 Catalogue Number: 314-02-02
• 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: 05/21/2025
• Initial Report FDA Received Date: 05/21/2025
• 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 Age: 75 YR
• Patient Sex: Female