MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 38MM HUM LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-38-00
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Osteolysis (2377); Joint Impingement (4834)
Date of Event	06/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 5 years and 11 months post the initial right reverse total shoulder arthroplasty, the patient experienced continued stiffness and pain.The surgeon completed diagnostic arthroscopes of the shoulder subsequently, but found no evidence of infection.On x-ray, scapula notching of the humeral poly was noted.Upon exposure, significant osteolysis of the proximal humeral bone and inferior glenoid was noted.The polyethylene liner was significantly damaged, medially, likely where it had been impinging on the scapula.The glenoid and humerus were well fixed before removal.Removal of the glenosphere revealed apparently infection between the baseplate and the glenosphere.The surgeon is awaiting results of samples taken, but provisionally ruled infection as the primary cause of revision.The surgeon removed all implants and placed a competitor antibiotic spacer in situ with the intention of inserting a second reverse in the future.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: 01000019015 (b)(6), - gps implant kit v2, (b)(6), 531-20-00 - shldr gps rvrs drill kit, (b)(6), 300-01-13 - equinoxe, humeral stem primary, press fit 13mm, (b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0, (b)(6), 320-15-02 - rs glenoid plate sup aug 10 deg, (b)(6), 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm, (b)(6), 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm, (b)(6), 320-20-00 - eq reverse torque defining screw kit, (b)(6), 320-15-05 - eq rev locking screw, (b)(6), 320-01-38 - equinoxe reverse 38mm glenosphere, (b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm, (b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b3.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h6, h11.Operative notes and/or medical records were not provided for review of usage/ technique.A definitive root cause was unable to be determined; however, may have resulted from infection and prosthesis wear.The cause of infection cannot be conclusively determined; however, it may be related to an underlying patient condition.The wear noted on the explanted humeral liner may be the result of impingement with the scapula secondary to a malpositioned glenoid baseplate.However, infection and the series of events cannot be confirmed and potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not returned for evaluation and additional post-operative radiographs were not provided.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 38MM 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: 22342128
• Report Number: 1038671-2025-02380
• Device Sequence Number: 9160656
• Product Code: KWT
• UDI-Device Identifier: 10885862086655
• UDI-Public: 10885862086655
• 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: 2019
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2025

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 Expiration Date: 05/11/2024
• Device Catalogue Number: 320-38-00
• 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: 06/13/2025
• Supplement Date Received by Manufacturer: 08/21/2025; 08/28/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 08/26/2025; 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2019
• 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: 74 YR
• Patient Sex: Female