MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE STEMLESS HUMERAL COMP LASER CAGE, SIZE 3; PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM WITH NO

Catalog Number	300-60-03
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); Inadequate Osseointegration (2646)
Date of Event	08/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant devices: 310-61-53 - stemless humeral head 53mm x 20mm x beta; 314-13-35 - cage glenoid xl, post aug, right.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.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
Approximately 3 year(s), 8 month(s) and 14 day(s) post-operative of a right tsa, it was reported via clinical study that the patient experienced aseptic glenoid loosening.Patient developed shoulder pain about 3 months ago with increasing pain, changing rom, and night pain.Radiolucency over glenoid peg and peri-hardware; osteolysis over stemless humeral component.The patient was administered esr/crp to rule out infection with plan for revision to reverse (type unspecified) pending labs.The outcome of this event is considered continuing and the case report form indicates that this event is possibly related to the device and/or to the procedure.This was reported through clinical trial study data collection activities and no other information is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.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
Approximately 3 year(s), 8 month(s) and 14 day(s) post-operative of a right tsa, it was reported via clinical study that the patient experienced aseptic glenoid loosening.Patient developed shoulder pain about 3 months ago with increasing pain, changing rom, and night pain.Radiolucency over glenoid peg and peri-hardware; osteolysis over stemless humeral component.The patient was administered esr/crp to rule out infection with plan for revision to reverse (type unspecified) pending labs.In a recent update, the patient underwent a standard total with stemless revision, with the reported removal of the glenoid, stemless humeral head, and stemless humeral cage components.The outcome of this event is now considered resolved and the case report form indicates that this event is possibly related to the device and/or to the procedure.This was reported through clinical trial study data collection activities and no other information is available at this time.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined that this device did not cause or contribute to the reported event.As a result, this device is no longer considered reportable by exactech and this report may be disregarded.

• Brand Name: EQUINOXE STEMLESS HUMERAL COMP LASER CAGE, SIZE 3
• Common Device Name: PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM WITH NO
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 20895061
• Report Number: 1038671-2024-04743
• Device Sequence Number: 8709873
• Product Code: PKC
• UDI-Device Identifier: 10885862559296
• UDI-Public: 10885862559296
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K192097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2025

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?: No
• 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: 11/25/2024
• Supplement Date Received by Manufacturer: 03/03/2025; 04/29/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 03/05/2025; 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 128 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White