MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 42MM HUM LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	320-01-42
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 70 years post op the initial left reverse tsa, this 70 y/o male patient was revised due to dislocation.The poly was disassociated from the tray.Patient was last known to be in stable condition following the event.Device is not returning, product was sent to spd.
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 300-01-13 - equinoxe, humeral stem primary, press fit 13mm 4006628, 320-10-05 - equinoxe reverse tray adapter plate tray +5 4018756, 320-15-01 - eq rev glenoid plate 4022980, 320-15-05 - eq rev locking screw 4019110, 320-20-00 - eq reverse torque defining screw kit 4007998, 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm 3967635, 320-20-42 - eq rev compress screw lck cap kit, 4.5 x 42mm 3989234, 320-20-46 - eq rev compress screw lck cap kit, 4.5 x 46mm 4019449, 4019468, 320-42-00 - equinoxe reverse 42mm humeral liner +0 3925448.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of a combination of dislocation and humeral liner disassociation.It is unclear if the dislocation allowed for the humeral liner to disassociate or if the humeral liner disassociation-which may have been the result of either incomplete seating of the liner during implantation, bone impingement, patient conditions, or any combination of these possibilities-led to the dislocation as the explanted devices were not returned for evaluation and images/pre-revision radiographs were unable to be obtained.Section h11: *the following sections have corrected information: (h6) component code: 4755, part/component/sub-assembly term not applicable.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b2, d1, d4, d8, g4 h6: medical device problem codes, component code, investigation conclusion.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: 145-DEG PE 42MM HUM LINER +0
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15502131
• Report Number: 1038671-2022-01190
• Device Sequence Number: 5438601
• Product Code: KWT
• UDI-Device Identifier: 10885862086693
• UDI-Public: 10885862086693
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 01/17/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/11/2020
• Device Model Number: 320-01-42
• Device Catalogue Number: 320-42-00
• Device Lot Number: 10081294
• 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: 09/09/2022
• Supplement Date Received by Manufacturer: 06/08/2023; 01/07/2026
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 06/29/2023; 01/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2015
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 102 KG