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

Model Number	320-01-42
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event	01/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: (b)(4), 300-01-13 - equinoxe, humeral stem primary, press fit 13mm.(b)(4), 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(4), 320-15-02 - rs glenoid plate sup aug, 10 deg.(b)(4), 320-15-05 - eq rev locking screw.(b)(4), 320-20-00 - eq reverse torque defining screw kit.(b)(4), 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.(b)(4), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.(b)(4), 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm.(b)(4), 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm.(b)(4), 320-42-00 - equinoxe reverse 42mm humeral liner +0.(b)(4), 531-20-00 - shldr gps rvrs drill kit.(b)(4), 531-78-20 - shouldr gps hex pins kit.(b)(4), a10012 - gps implant kit v2.
Event or Problem Description
As reported, the male patient had an initial left tsa on (b)(6) 2021.The event was a stage 1 revision of an exactech reverse shoulder.The implants were removed with an antibiotic spacer implanted.At this stage the plan is to revise to an exactech navigated shoulder once the infection is gone.There was no reported surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.
Additional Manufacturer Narrative
H3: 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 infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d1, d4, d10, g4, h4, h6, h11.D10: (b)(6), 320-01-42 - equinoxe reverse 42mm glenosphere.(b)(6), 300-01-13 - equinoxe, humeral stem primary, press fit 13mm.(b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6), 320-15-02 - rs glenoid plate sup aug, 10 deg.(b)(6), 320-15-05 - eq rev locking screw.(b)(6), 320-20-00 - eq reverse torque defining screw kit.(b)(6), 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.(b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.(b)(6), 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm.(b)(6), 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm.(b)(6), 320-42-00 - equinoxe reverse 42mm humeral liner +0.(b)(6), 531-20-00 - shldr gps rvrs drill kit.(b)(6), 531-78-20 - shouldr gps hex pins kit.(b)(6) - gps implant kit v2.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 complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, may have resulted from the patient¿s underlying condition.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE REVERSE 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16419854
• Report Number: 1038671-2023-00204
• Device Sequence Number: 5341353
• Product Code: KWT
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/07/2026

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: 320-01-42
• Device Catalogue Number: 320-01-42
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2023
• Supplement Date Received by Manufacturer: 06/12/2023; 04/21/2026
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 06/26/2023; 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2020
• 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; SEE H10.; SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male