MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 17MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	300-01-17
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Approximately 1 month(s) and 10 day(s) post-operative of a right rtsa, it was reported that the patient experienced infection.The patient underwent standard reverse and was revised with exactech devices.The patient's bone quality was not optimal as they needed to cement a 17 stem.It was further noted that due to the infection, incision and drainage was needed and the stem was found to be loose after the tray and liner were removed.The event was not related to the breakage of a device and did not lead to a surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other issues or complications were reported and the devices will not be returning for evaluation due to hospital policy.
Additional Manufacturer Narrative
Pending investigation.Concomitants: 320-08-42 - glenosphere exp 42mm +4mm offset, (b)(6); 320-15-05 - eq rev locking screw, (b)(6); 320-15-06 - rs glenoid plate ext cag +10mm cage peg, (b)(6); 320-20-00 - eq reverse torque defining screw kit, (b)(6); 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm, (b)(6); 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm, (b)(6); 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm, (b)(6); 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm, (b)(6); 320-20-46 - eq rev compress screw lck cap kit, 4.5 x 46mm, (b)(6); 321-52-07 - 3.2mm drill bit sterile, (b)(6); 322-10-00 - humeral adapter tray, +0, (b)(6); 322-42-03 - 145-deg pe 42mm hum liner +2.5, (b)(6).
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: g3, h6, h11.Mdr section codes updated/corrected: b, c, g.The revision was likely the result of infection as reported.A secondary finding during the revision was the humeral stem loosening.However, the reported infection and loosening cannot be confirmed and potential contributions of user-related considerations to the event could not be assessed as the devices were not returned for evaluation and product images were 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: EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 17MM
• 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, INC.; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20570412
• Report Number: 1038671-2024-04190
• Device Sequence Number: 15477813
• Product Code: KWS
• UDI-Device Identifier: 10885862079343
• UDI-Public: 10885862079343
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K061454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 09/24/2025

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 Catalogue Number: 300-01-17
• 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: 10/28/2024
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2024
• 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 Age: 56 YR
• Patient Sex: Male