MAUDE Adverse Event Report: EXACTECH, INC. EQ REV LOCKING SCREW; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-15-05
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 10 months after initial right tsa, the patient was revised after feeling pain while doing handy work.The glenosphere was loose and was replaced along with a new poly liner and screw.The event is related to the breakage of a device.All pieces that fell into the wound site were removed.The event did not lead to a surgical delay/prolongation.
Additional Manufacturer Narrative
Pending investigation.D10: (b)(6), 300-30-11 - equinoxe preserve stem 11mm.(b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6), 320-15-05 - eq rev locking screw.(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), 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.(b)(6), 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6), 320-35-01 - small glenoid plate.(b)(6), 320-40-00 - 145-deg pe 40mm hum liner +0.(b)(6), 321-20-00 - equinoxe reverse shoulder drill kit.(b)(6), 321-52-10 - 3.2mm k-wire, thd, short 2 k-wires per pack.
Additional Manufacturer Narrative
*the following sections have corrected information: (d1) brand name: eq rev locking screw, product code: kwt, common device name: prosthesis, shoulder, non-constrained, metal/polymer cemented, catalog number: 320-15-05, expiration date: 30-jul-2028, serial number: (b)(6), unique identifier (udi) #: (b)(4).(h4( device manufacture date: 02-aug-2023.(h6) medical device problem code: 2907 - detachment of device or device component.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: g4, h6.Mdr section codes updated/corrected: b, c, d, g.The revision reported was likely the result of disassembly of the glenosphere locking screw from the glenoid baseplate.The deformation observed on the explanted locking screw could have resulted from abnormal articulation as the screw backed out over time or incomplete seating at the time of implantation.A secondary finding of prosthesis wear likely resulted from abnormal articulation between the liner and glenoid baseplate following the locking screw disassembly.However, the series of events cannot be confirmed from the information provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQ REV LOCKING SCREW
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19728721
• Report Number: 1038671-2024-02371
• Device Sequence Number: 8274947
• Product Code: KWT
• UDI-Device Identifier: 10885862086495
• UDI-Public: 10885862086495
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2025
• 2 Devices were Involved in the Event: 1 2

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 Catalogue Number: 320-15-05
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: 07/12/2024; 10/17/2025
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 08/12/2024; 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male