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

Catalog Number	314-13-15
Medical Device Problem Codes	No Apparent Adverse Event (3189); Lack of Effect (4065)
Health Effect - Clinical Codes	Bacterial Infection (1735); Pain (1994); Loss of Range of Motion (2032)
Date of Event	02/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: humeral stem or stemless 300-01-15, humeral head 310-00-53, replicator plate 300-50-45.
Event or Problem Description
It was reported via clinical study that the 70 yo patient experienced a stiff shoulder, with reports of increased pain with limited rom in rt.Shoulder.Onset 5-6 months ago ((b)(6) 2021).No traumatic injury noted.The patient will follow up if needed after 6 weeks of physical therapy.The outcome was last known as continuing.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b3, b5, d1, d4, d6b, d10, g1, g4, h3, h6 and h11.D10: 300-01-15 - equinoxe, humeral stem primary, press fit 15mm 4356771.300-20-02 - equinox square torque define screw drive kit 4968290.300-50-45 - 4.5mm short rep plate 4602654.310-00-53 - equinoxe, humeral head, extra short, 53mm 4297682.314-13-15 - equinoxe cage glenoid extra large, beta 4224315.315-35-00 - glnd kwire 4723415.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 definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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
It was reported that the patient underwent an initial total shoulder replacement on the right side.Subsequently, approximately 4 years post-op, the patient experienced a stiff shoulder, with reports of increased pain and limited rom.No traumatic injury noted and the patient will follow up if needed after 6 weeks of physical therapy.2 weeks following the initiation of physical therapy it was noted that the patient had a deep infection.Elevated sedimentation rate and crp.Suspected p-acnes infection.As a result, approximately 6 years after initial replacement, the patient underwent a revision to the right shoulder.No further impact to the patient was reported.No other information is available.

• Brand Name: EQUINOXE PRIMARY SHOULDER COMPONENTS
• 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 66th ct; gainesville, FL 32653
• MDR Report Key: 17451923
• Report Number: 1038671-2023-01806
• Device Sequence Number: 17959380
• Product Code: KWS
• UDI-Device Identifier: 10885862172723
• UDI-Public: 10885862172723
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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
• Device Catalogue Number: 314-13-15
• 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: 06/30/2023
• Supplement Date Received by Manufacturer: 01/20/2024
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 H10.
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Race: White