MAUDE Adverse Event Report: EXACTECH, INC. RS GLENOID PLATE L POST AUG, 8 DEG, LEFT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-15-03
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Fall (1848); Unspecified Infection (1930); Pain (1994)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
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: 300-01-11 - equi, hum stem primary, press fit 11mm: (b)(6), 320-01-38 - equi reverse 38mm glenosphere: (b)(6), 320-10-00 - equi rev tray adapter plate tray +0: (b)(6), 320-15-05 - eq rev locking screw: (b)(6), 320-20-00 - eq rev torque defining screw kit: (b)(6), 320-20-22 - eq rev comp scr lck cap kit, 4.5 x 22mm: (b)(6), 320-20-26 - eq rev comp scr lck cap kit, 4.5 x 26mm: (b)(6), 320-20-26 - eq rev comps scr lck cap kit, 4.5 x 26mm: (b)(6), 320-20-26 - eq rev compress scr lck cap kit, 4.5 x 26mm: (b)(6), 320-38-00 - equi rev 38mm humeral liner +0: (b)(6).
Event or Problem Description
As reported, approximately 6 years and 5 months post the initial left reverse total shoulder arthroplasty, the patient complained about mild pain in the shoulder and presented with loosening on the glenoid side.Whether this is caused by fall or infection is unconfirmed.The surgeon removed the implants.There was no reported breakage of a device or surgical delay/prolongation.The patient as 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: h6, h11.The following sections were corrected: h6.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 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 glenoid loosening as reported.However, the loosening cannot be confirmed and any potential contributions from manufacturing, user, or patient-related contributing factors to the event cannot be evaluated as the devices were not returned for evaluation, and no clinical information, radiographs, or images were provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: RS GLENOID PLATE L POST AUG, 8 DEG, LEFT
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-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: 22558829
• Report Number: 1038671-2025-02528
• Device Sequence Number: 9566271
• Product Code: KWS
• UDI-Device Identifier: 10885862186683
• UDI-Public: 10885862186683
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• 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
• 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 Catalogue Number: 320-15-03
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2018
• 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
• Patient Age: 84 YR
• Patient Sex: Male