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

Catalog Number	314-13-13
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial anatomic shoulder replacement of their right side.Subsequently, the patient reported experiencing pain.As a result, the patient underwent a right shoulder revision on approximately 5 years and 10 months after initial replacement.It was noted that the poly component was worn.No further patient impact reported.
Additional Manufacturer Narrative
D10: (b)(6), 300-01-13 - equinoxe, humeral stem primary, press fit 13mm.(b)(6), 300-10-45 - equinoxe replicator plate 4.5mm o/s.(b)(6), 300-20-02 - equinox square torque define screw drive kit.(b)(6), 310-01-47 - equinoxe, humeral head short, 47mm (beta).Customer has indicated that the product is in process of being returned for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d9, h3, h6 - component code, type of investigation, investigation findings, investigation conclusions and h11 the complaint device was evaluated, and the reported event was confirmed.The evaluation identified discoloration that appears consistent with sub-surface damage.There appears to be scratches on the articular surface that likely resulted from contact with surgical tools during removal.The glenoid component was returned with two detached metal pegs¿one that was separated cleanly from the polyethylene peg likely during the extraction process, and one that retained the polyethylene peg and fractured from the glenoid.There also appears to be damage on the superior portion of the backside of the glenoid.Based on the fracture surface of the polyethylene and the damage observed, it appears that the peripheral peg likely fractured prior to the revision surgery and was contacting the backside of the glenoid component.However, this cannot be confirmed because serial radiographs were not provided.The center cage was not returned with the glenoid.Based on the condition of the remaining polyethylene post, it is likely that the center cage was removed intentionally during the revision surgery.However, this cannot be confirmed from the information provided.All other aspects of the device appear unremarkable.Operative notes and/or medical records were not provided for review of usage/ technique.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, the revision reported was likely the result of prosthesis wear, prosthesis fracture, and/or inclusion of the polyethylene component in the packaging recall.Potential contributions from user or patient-related considerations to the event could not be assessed because 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: EQUINOXE CAGE GLENOID MEDIUM, 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21987992
• Report Number: 1038671-2025-02008
• Device Sequence Number: 20952226
• Product Code: KWS
• UDI-Device Identifier: 10885862172693
• UDI-Public: 10885862172693
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/17/2021
• Device Catalogue Number: 314-13-13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2016
• 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: 65 YR
• Patient Sex: Male