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

Catalog Number	320-15-06
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation : concomitant medical products : 300-01-14 - equinoxe humeral stem primary press fit 14mm; 320-38-00 - equinoxe reverse 38mm humeral liner +0; 320-10-00 - equinoxe reverse tray adapter plate tray +0; 320-15-06 - rs glenoid plate ext cag +10mm cage peg.
Event or Problem Description
It was reported by the equinoxe shoulder study, that this 55 y/o male patient experienced aseptic glenoid loosening.At 2-year follow-up visit x-rays revealed glenoid loosening; however, patient reports no pain in right shoulder.The case report form indicates this event is possibly related to devices and/or procedure.This event report was received through clinical data collection activities.No action taken, outcome is continuing.320-15-06 - rs glenoid plate ext cag +10mm cage peg.
Additional Manufacturer Narrative
(h3) the glenoid baseplate loosening reported was likely the result of an insufficient bond between the glenoid baseplate and the bone and/or patient-related conditions.However, this cannot be confirmed as the devices and radiographs were not available for evaluation.The following sections have corrected information: (b5) describe event or problem: it was reported by the equinoxe shoulder study, that this 55 y/o male patient experienced aseptic glenoid loosening.At 2-year follow-up visit x-rays revealed glenoid loosening; however, patient reports no pain in right shoulder.The case report form indicates this event is possibly related to devices and/or procedure.This event report was received through clinical data collection activities.No action taken, outcome is continuing.(d1) brand name: rs glenoid plate ext cag +10mm cage peg, product code: kwt, common device name: prosthesis, shoulder, non-constrained, metal/polymer cemented (d4) catalog number: 320-15-06, unique identifier (udi) #: (b)(4).(d10) concomitant device(s): 300-01-14 - equinoxe humeral stem primary press fit 14mm.320-38-00 - equinoxe reverse 38mm humeral liner +0.320-10-00 - equinoxe reverse tray adapter plate tray +0.320-06-38 - glenosphere 38mm.
Event or Problem Description
It was reported by the equinoxe shoulder study, that this 55 y/o male patient experienced aseptic glenoid loosening.At 2-year follow-up visit x-rays revealed glenoid loosening; however, patient reports no pain in right shoulder.The case report form indicates this event is possibly related to devices and/or procedure.This event report was received through clinical data collection activities.No action taken, outcome is continuing.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b2, b3 (remove erroneous date from initial report - remains implanted), d4 (serial number and expiration date), g2, h4, h6 clinical code, impact code, types of investigation, investigation findings and investigation conclusions.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 EXT CAG +10MM CAGE PEG
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16291027
• Report Number: 1038671-2023-00095
• Device Sequence Number: 14762863
• Product Code: KWT
• UDI-Device Identifier: 10885862186706
• UDI-Public: 10885862186706
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2023
• Supplement Date Received by Manufacturer: 04/18/2023; 04/22/2026
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 05/09/2023; 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2019
• 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 H10.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 126 LB
• Patient Race: White