MAUDE Adverse Event Report: EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	320-40-03
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Dislocation (2374); Insufficient Information (4580)
Date of Event	12/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the equinoxe shoulder study, approximately 1 year and 1 month post right tsa implantation, the 53 y/o male patient presented with a dislocation."he was doing well until late 2022 when following a vigorous workout in the gym he sustained a dislocation of the right shoulder while turning over in bed.He required an emergency room reduction at a local hospital and has been fine since that time.He had no symptoms prior to this instability episode." the action taken was closed reduction in er.The outcome of this event is considered resolved and the clinical study report indicates this event is definitely related to the device(s) and/or to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.
Additional Manufacturer Narrative
(d10) concomitant device(s): 320-40-03 - 145-deg pe 40mm hum liner +2.5 : 6538367 300-30-07 - equinoxe preserve stem 7mm : 6702244 315-35-00 - glnd kwire : 6670696 320-10-00 - equinoxe reverse tray adapter plate tray +0 : 6723400 320-31-40 - glenosphere, 40mm : 6385961 320-35-01 - small glenoid plate : 6636380 320-15-05 - eq rev locking screw : 6692527 320-20-00 - eq reverse torque defining screw kit : 6710626 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm : s117127 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm : s117128 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm : s121271 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm : s121300 321-52-07 - 3.2mm drill bit sterile : 6604982 pending evaluation.
Additional Manufacturer Narrative
The cause of the patient¿s shoulder dislocation and subsequent closed reduction reported cannot be conclusively determined; however, it may be due to soft tissue imbalance, patient anatomy, implant positioning, and/or implant selection.Dislocation is a known risk, as outlined in the ifu.D1: corrected.D4/d6: device, serial #, udi #, expiration, implant and explant dates unknown.G3: manufactured dates unknown.G4: pma 510k cannot be determined.H6: corrected health effect, medical device, and investigation clinical codes.

• Brand Name: SPECIFIC DEVICE NOT REPORTED
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19356507
• Report Number: 1038671-2024-01359
• Device Sequence Number: 20436833
• Product Code: PHX
• UDI-Device Identifier: 10885862535047
• UDI-Public: 10885862535047
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/17/2025
• Device Catalogue Number: 320-40-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/01/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2024
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2020
• 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
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Race: White