MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 40MM CONST HUM LINER +2.5; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	320-40-13
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	10/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: (b)(6) 300-01-11 - equinoxe, humeral stem primary, press fit 11mm (b)(6) 320-35-08 - small superior/posterior augglenoid plate,right (b)(6) 320-20-00 - eq reverse torque defining screw kit (b)(6) 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm (b)(6) 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm (b)(6) 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm (b)(6) 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm (b)(6) 320-32-40 - expanded glenosphere, 40mm, for small reverse (b)(6) 320-15-05 - eq rev locking screw (b)(6) 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm (b)(6) 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.
Event or Problem Description
As reported, the patient underwent a third right side shoulder revision surgery due to instability after her reverse replacement.The humeral tray was revised from a 0 to a +10.The poly was also revised to a constrained liner.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Report number: 1038671-2024-04401 this follow-up report is being submitted to relay additional and/or corrected information.The product associated with the reported event is within the scope of recall z-1421-2024; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The cause of the patient¿s shoulder dislocation and instability reported cannot be conclusively determined; however, it may be due to soft tissue imbalance, patient anatomy, implant positioning, and/or implant selection.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: 145-DEG PE 40MM CONST HUM LINER +2.5
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20694905
• Report Number: 1038671-2024-04403
• Device Sequence Number: 12400969
• Product Code: PHX
• UDI-Device Identifier: 10885862535061
• UDI-Public: 10885862535061
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2025

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 Expiration Date: 01/26/2025
• Device Catalogue Number: 320-40-13
• 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: 10/30/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2020
• 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 H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female