MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE PRIMARY SHOULDER; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	300-60-03
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 2 years post the initial left total shoulder arthroplasty, the patient was revised due to loosening.The components were removed and an antibiotic spacer was implanted.The patient was not revised to exactech devices.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
Pending investigation.Concomitants: (b)(6) a10012 - gps implant kit v2.(b)(6) 314-13-24 - equinoxe cage glenoid l, post aug, left.(b)(6) 300-60-03 - stemless humeral comp laser cage, size 3.(b)(6) 310-62-47 - stemless humeral head 47mm x 15mm x beta.(b)(6) 319-01-32 - steinmann pin sterile 3.2mm x 178mm.(b)(6) 531-78-20 - shouldr gps hex pins kit.(b)(6) 531-78-20 - shouldr gps hex pins kit.
Additional Manufacturer Narrative
The revision reported may have been due to loosening and infection as reported.Secondary findings include prosthesis wear and fracture of the glenoid component, likely due to proximal migration of the humeral components relative to the glenoid and/or off-axis drilling of the peripheral pegs holes resulting in a rocking horse effect around a well-fixed cage.However, loosening, infection, and the series of events could not be confirmed from the provided information.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and initial post-operative radiographs were not provided.B3: corrected.D1: corrected.D4: corrected.G4: corrected.H4: corrected.H6: corrected health effect, component, and investigation clinical codes.

• Brand Name: EQUINOXE PRIMARY SHOULDER
• 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: 20422598
• Report Number: 1038671-2024-03925
• Device Sequence Number: 7608159
• Product Code: KWS
• UDI-Device Identifier: 10885862559296
• UDI-Public: 10885862559296
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K192097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 07/14/2025

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: 300-60-03
• 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: 10/02/2024
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 07/14/2025
• Date Device Manufactured: 03/01/2021
• 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 Sex: Male