MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE ANATOMIC SHOULDER SYSTEM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	EQUINOXE REPLICATOR PLATE 1.5MM O/S
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	07/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 1.5 years post initial left tsa, the 79 y/o female patient had an anatomic shoulder converted to a reverse shoulder due instability caused by a deficient rotator cuff.Patient was revised to a reverse standard glenoid, 4 bone screws 38mm glenosphere 0 spacer plate 38mm poly 8 insert.There was no breakage of a device and no surgical delay/prolongation.Patient was last known to be in stable condition following the event.The device is not available for evaluation due to pathology lab has discarded the devices.No additional information.
Additional Manufacturer Narrative
Concomitant medical products: equinoxe, humeral head short, 41mm (alpha) (cat# 310-01-41 / serial# (b)(4)), equinoxe sq torque defining screw assembly (cat# 300-11-00 / serial# (b)(4)).As reported, approximately 1.5 years post initial left tsa, the 79 y/o female patient had an anatomic shoulder converted to a reverse shoulder due instability caused by a deficient rotator cuff.Patient was revised to a reverse standard glenoid, 4 bone screws 38mm glenosphere 0 spacer plate 38mm poly 8 insert.There was no breakage of a device and no surgical delay/prolongation.Patient was last known to be in stable condition following the event.The device is not available for evaluation due to pathology lab has discarded the devices.No additional information.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition a deficient rotator cuff.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d1, d4 (remove all from initial report-suspect product unknown), d10, g3 (remove 501k from initial report-unknown), h4 (remove erroneous entered date from initial), h6: clinical code, medical device problem code, component code, type of investigation, investigation conclusion.D10: equinoxe, humeral head short, 41mm (alpha) (cat# 310-01-41 / serial# (b)(6).Equinoxe sq torque defining screw assembly (cat# 300-11-00 / serial# (b)(6).Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE ANATOMIC SHOULDER SYSTEM
• 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15264975
• Report Number: 1038671-2022-00950
• Device Sequence Number: 17786291
• Product Code: KWT
• UDI-Device Identifier: 10885862079381
• UDI-Public: 10885862079381
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2025

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 Model Number: EQUINOXE REPLICATOR PLATE 1.5MM O/S
• Device Catalogue Number: 300-10-15
• Device Lot Number: 03121793
• 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: 07/22/2022
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 08/22/2022
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2017
• 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 HUMERAL STEM; SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female