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

Catalog Number	314-13-33
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Osteolysis (2377)
Date of Event	10/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient, initial anatomic right shoulder implanted in (b)(6) 2017, has been experiencing increasing pain in their shoulder for the last 3 years.They were contacted by their doctor to hava a ct scan and an appointment to have him look at the issues.The ct scan and the subsequent ultrasound showed excessive wear and loosening of the glenoid, particle build up, and inflammation.The patient is requesting the process to rectify this urgently as the pain and discomfort is becoming unbearable.No images were available.No further information.
Additional Manufacturer Narrative
D10: concomitants: 310-02-50 - equinoxe, humeral head tall, 50mm (beta) 2898516; 300-20-02 - equinox square torque define screw drive kit 4802827; 300-01-11 - equinoxe, humeral stem primary, press fit 11mm 4827395; 300-10-45 - equinoxe replicator plate 4.5mm o/s 4899856; a10012 - gps implant kit v2 5005017074.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a3, b3, b5, d6b, h6 - "f" code.
Event or Problem Description
The male patient underwent a revision procedure on (b)(6) 2025, approximately 7 years 6 months post the initial procedure.It was determined there was osteolysis around the glenoid pegs and in the proximal humerus.Everything was removed.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.No x-rays were provided.The devices are not available for return as they were disposed by the customer.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6 the following sections were corrected: b2 b3 d1 h3: device not returned h6 the revisions reported may have been the result of prosthesis wear and loosening of the glenoid component.However, this cannot be confirmed and potential contributions from implant positioning and user or patient related considerations to the event could not be assessed since the devices were not returned for evaluation, and no images or radiographs were 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 M, POST AUG, RIGHT
• 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 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 20505127
• Report Number: 1038671-2024-04070
• Device Sequence Number: 18216717
• Product Code: KWS
• 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: 2017
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2025

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: 02/01/2020
• Device Catalogue Number: 314-13-33
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: 01/16/2025; 01/24/2025
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 01/22/2025; 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2015
• 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; Hospitalization; Other
• Patient Sex: Male