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

Model Number	300-30-10
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Subclinical Infection (2247)
Date of Event	08/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via clinical study (intra-op) that the 80-year-old white male patient experience (septic loosening) anterior shoulder pain without injury for 6 months.The date of event onset is (b)(6) 2022.The patient¿s outcome was last known as continuing.The case report form indicates this event is definitely not related to device or procedure.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Concomitant medical device(s): 320-42-00 equinoxe reverse 42mm humeral liner +0; 320-10-00 equinoxe reverse tray adapter plate tray +0; 320-01-42 equinoxe reverse 42mm glenosphere; 320-15-04 rs glenoid plate r post aug, 8 deg, right.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H6: in a review of the labeling, it is a known complication that a patient¿s age, weight, activity level, and/or trauma would cause the surgeon to expect early failure of the system.As part of the preoperative assessment, the surgeon must ensure that no biological, biomechanical, or other factors exist that might adversely affect the surgery and/or postoperative period.Revisions or surgical interventions are a known complication found in joint replacements.A contraindication for use is any disease state that could adversely affect the function or longevity of the implant.Excessive activity and trauma affect joint replacements and can cause the failure of an implant.Only qualified surgeons knowledgably in anatomy, biomechanics and reconstructive surgery should use these devices.The surgeon must be fully knowledgeable about all aspects of the equinoxe surgical technique and use the implants in accordance with the indications and contraindications.The surgeon must be fully knowledgeable about the surgical technique and trained according to the proper use of the system instrumentation and implants.Infection is a known joint replacement risk.Device specific risks include excessive wear of the implant components secondary to impingement of components or damage of articular surfaces can cause early device failure.That there are device specific risks of fracture, migration, loosening, subluxation, or dislocation of the prothesis or any of its components, and any of which may require a second surgical intervention or revision.Infection is a clinically well-known potential complication of any surgical procedure including shoulder arthroplasty.If infection occurs after shoulder replacement, whether related to the procedure or otherwise, the foreign metal and plastic implants can serve as a surface for the bacteria to latch onto, inaccessible to antibiotics.Even if the implants remain well fixed, the pain, swelling, and drainage from the infection make the revision surgery necessary.With current surgical techniques and antibiotic regimens, the rate of infection following shoulder replacement is 1.8% for primary and 4% for reverse shoulders.The highest risk period for infection is the first two years following the surgery.J.S.Coste, s.Reig, c.Trojani, m.Berg, g.Walch, p.Boileau.¿the management of infection in arthroplasty of the shoulder¿.The journal of bone and joint surgery (br).January 2004; 86-b: 65-9.& w.Zimmerli, a.Trampuz, p.E.Ochsner."prosthetic-joint infections".The new england journal of medicine.October 2004; 351:1645-54 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 surgical revision for infection cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information: please disregard this report as it was submitted in error.Event was previously reported under report # 1038671-2022-01615.

• Brand Name: EQUINOXE
• 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; 22320 nw 66th court; gainesville FL 32563
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16338731
• Report Number: 1038671-2023-00131
• Device Sequence Number: 6430966
• Product Code: KWS
• UDI-Device Identifier: 10885862515780
• UDI-Public: 10885862515780
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2026

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 Model Number: 300-30-10
• Device Catalogue Number: 300-30-10
• 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: 01/19/2023
• Supplement Date Received by Manufacturer: 01/19/2023; 02/05/2026
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 04/03/2023; 02/05/2026
• 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 H10
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Race: White