MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID M, POST AUG, RIGHT; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	314-13-33
Medical Device Problem Codes	Fracture (1260); Insufficient Device Problem Information (3190); Lack of Effect (4065)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032)
Date of Event	10/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient's right shoulder was revised approximately 4 years 8 months post op.The patient complained about some mild pain & reduced movement in shoulder.Surgeon suspected implant failure, which was confirmed via ct scan and during removal with a spacer constructed and left in.First stage revision completed with antibacterial spacer used to combat infection and maintain joint space.Patient was last known to be in stable condition following the event.Product not returning: discarded.
Additional Manufacturer Narrative
(d10) concomitant device(s): a10012 - gps implant kit v2, 02000019190; 310-01-50 - equinoxe, humeral head short, 50mm (beta), 5781097; 531-20-00 - shldr gps rvrs drill kit, 5785571; 314-13-33 - equinoxe cage glenoid m, post aug, right, 5937900; 300-10-15 - equinoxe replicator plate 1.5mm o/s, 6049466; 300-20-02 - equinox square torque define screw drive kit, 6159217; 300-01-13 - equinoxe, humeral stem primary, press fit 13mm, 6268694; 531-78-20 - shouldr gps hex pins kit, 6304251; 315-35-00 - glnd kwire, 6330390.
Additional Manufacturer Narrative
"this follow-up report is being submitted to relay additional and/or corrected information.The pain and reduced range of motion reported may be the result of the prosthesis fracture and infection as reported.However, this cannot be confirmed as no relevant clinical information, images, or radiographs were provided.The reason for the suspected infection cannot be conclusively determined; however, it may be related to an underlying patient condition.Potential contributions of patient or user-related issues to the event cannot be determined from the reported information.The product associated with the reported event is within the scope of recall z-1415-2024; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.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 M, POST AUG, RIGHT
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20599581
• Report Number: 1038671-2024-04218
• Device Sequence Number: 15652590
• Product Code: KWT
• UDI-Device Identifier: 10885862201010
• UDI-Public: 10885862201010
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2025

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: 03/25/2024
• Device Catalogue Number: 314-13-33
• 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: 10/16/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male