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	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Unspecified Infection (1930); Osteolysis (2377)
Date of Event	07/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 2 years and 2 months post the initial right total shoulder arthroplasty, the patient was revised due to a loose glenoid component with marked osteolysis of the glenoid due to polyethylene wear.Everything was removed.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
The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.D10: (b)(6) a10012 - gps implant kit v2.(b)(6) 314-13-34 - equinoxe cage glenoid l, post aug, right.(b)(6) 310-01-47 - equinoxe, humeral head short, 47mm (beta).(b)(6) 300-20-02 - equinox square torque define screw drive kit.(b)(6) 300-30-09 - equinoxe preserve stem 9mm.(b)(6) 300-10-45 - equinoxe replicator plate 4.5mm o/s.(b)(6) 531-78-20 - shouldr gps hex pins kit.(b)(6) 531-78-20 - shouldr gps hex pins kit.(b)(6) 315-35-00 - glnd kwire.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: g3.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h6, h11 no device was returned for evaluation; photographs of the device were provided; however, the reported event was unable to be confirmed.The review identified that the humeral liner appears to have notable wear on the superior rim of the articular surface.This wear could be consistent with impingement between the liner and the superior aspect of the glenoid.It is also possible that there was intra-articular force on the superior rim.In addition, the articular surface of the liner appears to be slightly discolored and roughened, which could be consistent with the impact of an infection.The infection also could have exacerbated the abrasive wear seen on the superior portion of the device.Operative notes and/or medical records were not provided for review of usage/ technique.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, may have resulted from prosthesis wear, infection, and/or inclusion of the polyethylene component in the packaging recall.However, the infection cannot be confirmed and potential contributions from user or patient-related considerations cannot be determined as the device was not returned for evaluation and relevant clinical information was not provided.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 corrected information.The following sections were corrected: a2, b3, b4, b5, d1, d2a, d2b, d4, d6a, d6b, d10, g3, g4, h4, h6.D10: 08011017016 a10012 - gps implant kit v2.4843732 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.4848938 320-42-00 - equinoxe reverse 42mm humeral liner +0.4974584 320-10-00 - equinoxe reverse tray adapter plate tray +0.4979760 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.4980729 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.4986362 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.5012158 320-01-42 - equinoxe reverse 42mm glenosphere.5075479 320-20-00 - eq reverse torque defining screw kit.5081787 320-15-05 - eq rev locking screw.5087106 300-01-11 - equinoxe, humeral stem primary, press fit 11mm.5118312 320-15-04 - rs glenoid plate post aug, 8 deg.
Event or Problem Description
It was reported that this patient underwent an initial tsa (total shoulder arthroplasty).Subsequently, the patient developed poly wear then developed infection due to a biopsy.As a result, the surgeon revised everything and a cement spacer was placed 6.5 years post the initial operation.The patient was last known to be in stable condition following the event.

• 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: 22559630
• Report Number: 1038671-2025-02533
• Device Sequence Number: 9699815
• Product Code: KWT
• UDI-Device Identifier: 10885862086693
• UDI-Public: 10885862086693
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/07/2025

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: 04/11/2022
• Device Catalogue Number: 320-42-00
• 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: 07/08/2025
• Supplement Date Received by Manufacturer: 07/14/2024; 07/08/2025; 10/06/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 07/25/2025; 08/18/2025; 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2017
• 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.; SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male