MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	12/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by the equinoxe shoulder study, approximately 1 year(s) and 7 month(s) post implantation of left a second revised tsa, the patient presented with aseptic glenoid loosening.Patient reports significant left shoulder pain and believes it is infected again.Patient feels shoulder is " not quite right" again.Denies constitutional symptoms to include fevers, chills, night pain.Approximately 9 months earlier, the report indicated unexplained pain in left shoulder.Wbc scan to rule out infection but having left shoulder pain.This was resolved a month later and scan negative for infection.Patient has no pain and doing better.This outcome of the event was resolved by repeat nuclear medicine, wbc scan, infection labs and finally a standard reverse revision of the left shoulder.The clinical report indicates that the event is possibly related to the device(s) and/or to the procedure.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: h6, h11.The following sections were corrected: h6 - clinical code.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 review of manufacturing data was unable to be performed as the lot information of the product involved in the event was not available.A review of complaint history was unable to be performed as the relevant device and event information was unknown.A definitive root cause was unable to be determined; however, may have resulted from humeral component loosening.However, the loosening cannot be confirmed and any potential contributions from manufacturing, user, or patient-related contributing factors to the event cannot be evaluated as 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, HUMERAL STEM PRIMARY, PRESS FIT 11MM
• 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: goeff gannon
• MDR Report Key: 19487962
• Report Number: 1038671-2024-01824
• Device Sequence Number: 7024930
• Product Code: KWS
• UDI-Device Identifier: 10885862079312
• UDI-Public: 10885862079312
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2025

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: 05/10/2026
• Device Model Number: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
• Device Catalogue Number: 300-01-11
• 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: 05/22/2024
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2016
• 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: EQUINOXE REVERSE 46MM HUMERAL LINER +2.5.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Race: White