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

Catalog Number	320-42-00
Medical Device Problem Codes	Unstable (1667); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526); Insufficient Information (4580)
Date of Event	11/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer has indicated that the product is in process of being returned for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.D10: 620-00-02 - platelet rich plasma kit with spray tips, (b)(6); 300-30-08 - equinoxe preserve stem 8mm, (b)(6); 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm, (b)(6); 320-20-42 - eq rev compress screw lck cap kit, 4.5 x 42mm, (b)(6); 320-20-00 - eq reverse torque defining screw kit, (b)(6); 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm, (b)(6); 321-20-00 - equinoxe reverse shoulder drill kit, (b)(6); 315-35-00 - glnd kwire, (b)(6); 320-15-01 - eq rev glenoid plate, (b)(6); 320-01-42 - equinoxe reverse 42mm glenosphere, (b)(6); 320-15-05 - eq rev locking screw, (b)(6); 320-10-00 - equinoxe reverse tray adapter plate tray +0, (b)(6); 620-12-02 - accelerate prp 60 ml & acd-a, (b)(6).
Event or Problem Description
As reported, approximately 4 years and 3 months post the initial right total shoulder arthroplasty, the liner dissociated and the patient was revised.There was no trauma event.A new glenosphere, liner, locking screw, and adaptor tray were implanted.All fragments, parts or pieces were removed.There was no reported surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: a3, a4, a6, d6b, g2, h6, and h11.The following sections were corrected: b5, h6 - clinical code.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
As reported, approximately 4 years and 3 months post the initial right total shoulder arthroplasty, the patient experienced disassociation of polyethylene with reported instability and dislocation resulting in disassociation of poly.The patient underwent a standard reverse with preserve stem revision.There was no trauma event.A new glenosphere, liner, locking screw, and adaptor tray were implanted.All fragments, parts or pieces were removed.There was no reported surgical delay/prolongation.The patient was last known to be in stable condition following the event.The outcome of this event is considered resolved and the case report form indicates that this event is definitely related to the device and/or to the procedure.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were added: d4 unique identifier (udi) #, and g4 pma/510(k)number.The following sections were corrected: d2a product code, d4 catalog number.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: b3, h6 mdr section codes updated/corrected: a, b, c, d, e, g the revision reported was likely the result of instability, dislocation, and disassembly between the humeral liner and humeral tray leading to metal-on-metal articulation between the glenosphere and adapter tray.The deformation of the humeral liner¿s locking mechanism may have contributed to the disassembly of the liner and the tray.The reported dislocation and instability may have caused the disassembly of the liner and adapter tray, as reported.Alternatively, the humeral liner disassociation may have caused the instability and dislocation, however either sequence of events cannot be confirmed based on the provided information.Potential contributions from patient conditions, an unreported traumatic event, incomplete seating of the humeral liner during implantation, forceful contact between the liner and glenoid bone (scapular notching), or a combination of the above to the disassembly of the humeral liner cannot be confirmed from the reported information.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 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20924532
• Report Number: 1038671-2024-04808
• Device Sequence Number: 5043112
• Product Code: KWT
• UDI-Device Identifier: 10885862086693
• UDI-Public: 10885862086693
• 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: 2020
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/24/2025

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: 03/04/2025
• Device Catalogue Number: 320-42-00
• 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: 11/22/2024
• Supplement Date Received by Manufacturer: 12/20/2024; Not provided; 09/22/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 12/23/2024; 01/29/2025; 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2020
• 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: Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Race: White