MAUDE Adverse Event Report: EXACTECH, INC. RS GLENOID PLATE EXT CAG +10MM CAGE PEG; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-15-06
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Unspecified Infection (1930); Medical device site infection (4845); Septic loosening (4884)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient underwent an initial right reverse total shoulder arthroplasty.Subsequently, the patient was infected and debridement, antibiotics and implant retention was planned.The glenoid plate was found to be loose and was removed.The tray and liner were also removed.Would have placed an anatomic humeral head to create a hemi, but this was not available, so the stem and hrp were left in-situ.The patient has no glenoid component.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
D10: 42mm glenosphere locking screw 42mm +0 liner reverse tray +0 baseplate screws and caps 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.

• Brand Name: RS GLENOID PLATE EXT CAG +10MM CAGE PEG
• 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: ashley harris ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 24567583
• Report Number: 1038671-2026-00252
• Device Sequence Number: 15549802
• Product Code: KWS
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K110708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• 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): 05/21/2026

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: 320-15-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 05/21/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown