MAUDE Adverse Event Report: EXACTECH, INC. RESURFACING CAGE, 25MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	312-01-01
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	03/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: pending investigation.D10: 5878117 300-01-13 - equinoxe, humeral stem primary, press fit 13mm 5257931 300-10-15 - equinoxe replicator plate 1.5mm o/s 5844016 310-01-41 - equinoxe, humeral head short, 41mm (alpha).
Event or Problem Description
As reported, the 69 year old female patient had an initial right tsa on an unknown date.The surgeon determined that the patient was in need of conversion from a hemi-arthroplasty to a reverse shoulder arthroplasty.The patient was revised on (b)(6) 2024.The surgeon removed the in-situ humeral head, torque break-off screw and replicator plate, but left the existing exactech equinoxe humeral stem in place.He prepared the glenoid and implanted reverse shoulder glenoid components and implanted reverse shoulder humeral side components.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
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: g1, g2, g3, h6, h11.Mdr section codes updated/corrected: b, c, d, e, g.The reason for the revision cannot be confirmed from the information provided but may be due to loosening, infection, fracture, instability, dislocation, rotator cuff tear, and/or patient related factors.Potential contributions of manufacturing, user, and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and relevant clinical information was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: RESURFACING CAGE, 25MM
• 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: 19149420
• Report Number: 1038671-2024-00914
• Device Sequence Number: 15434006
• Product Code: HSD
• UDI-Device Identifier: 10885862248565
• UDI-Public: 10885862248565
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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: 04/18/2023
• Device Catalogue Number: 312-01-01
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2018
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female