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

Catalog Number	314-13-14
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Osteolysis (2377); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
1038671-2025-00013 d10: (b)(6) 310-01-47 - equinoxe, humeral head short, 47mm (beta) (b)(6) 300-01-12 - equinoxe humeral stem primary press fit 12mm (b)(6) 300-10-45 - equinoxe replicator plate 4.5mm o/s (b)(6) 300-20-02 - equinox square torque define screw drive kit the product associated with the reported event is within the scope of recall z-1413-2024; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2025-00013.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 via legal documentation that approximately 69 months after a right total shoulder replacement procedure, the patient has has not underwent a revision procedure.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear or loosening or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.H1: corrected h6: corrected health effect and investigation clinical codes.H10 related report numbers: 1038671-2025-00013, 1038671-2025-02178, 1038671-2025-00099, 1038671-2025-02150.

• Brand Name: EQUINOXE CAGE GLENOID LARGE, BETA
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21085384
• Report Number: 1038671-2025-00096
• Device Sequence Number: 8428255
• Product Code: KWS
• UDI-Device Identifier: 10885862172716
• UDI-Public: 10885862172716
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/15/2024
• Device Catalogue Number: 314-13-14
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 05/28/2025
• Date Device Manufactured: 01/17/2019
• 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.
• Patient Sex: Unknown