MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 42MM HUM LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-42-03
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 320-42-03 - equinoxe reverse 42mm humeral liner +2.5 (b)(6);, 320-42-03 - equinoxe reverse 42mm humeral liner +2.5 (b)(6);, 300-01-15 - equinoxe, humeral stem primary, press fit 15mm (b)(6); 300-01-15 - equinoxe, humeral stem primary, press fit 15mm (b)(6); 320-10-00 - equinoxe reverse tray adapter plate tray +0 (b)(6); 320-15-02 - rs glenoid plate sup (b)(6), 10 deg (b)(6); 320-20-00 - eq reverse torque defining screw kit (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); 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm (b)(6); 620-00-02 - platelet rich plasma kit with spray tips (b)(6); 620-11-02 - accelerate conc.Sys rep by 620-12-02 (b)(6).Multiple mdr reports were filed for this event, please see associated reports 1038671-2023-00031.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 manufacturing data was unable to be performed as the lot information of the product involved in the event was not available.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported approximately six years after a reverse right total shoulder replacement the patient experienced pain.The patient underwent a right total shoulder revision procedure due to disassociation of the humeral tray, humeral liner, glenosphere and locking screw.No medical or surgical interventions were reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: a, g.The revision reported in was likely the result of humeral tray disassociation, likely leading to the reported humeral liner disassociation and glenosphere loosening.The humeral tray disassociation may have been the result of incomplete seating/cross-threading of the reverse torque defining screw and/or an unreported post traumatic event, which allowed the torque defining screw to back out.The glenosphere loosening may have been the result of abnormal articulation following the humeral liner/tray disassembly, incomplete seating of the glenosphere locking screw and/or the glenosphere on the baseplate at the time of implantation, or a combination of these possibilities.Following the humeral tray and liner disassociation, abnormal articulation between the metal components likely resulted in the reported noise.However, these allegations cannot be confirmed as the devices were not returned for evaluation and images/radiographs were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: 145-DEG PE 42MM HUM LINER +2.5
• 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
• MDR Report Key: 22436318
• Report Number: 1038671-2025-02433
• Device Sequence Number: 3153036
• Product Code: KWT
• UDI-Device Identifier: 10885862086709
• UDI-Public: 10885862086709
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2025

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 Catalogue Number: 320-42-03
• 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: 12/22/2022
• Supplement Date Received by Manufacturer: 10/15/2025; 10/21/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 10/21/2025; 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 120 KG
• Patient Race: White