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	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Osteolysis (2377); Aseptic loosening (4883)
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient received a reverse over a bone block 4 years ago.There was bone block resorption over time and the glenoid broke out.The patient was revised.There was no reported breakage of a device or surgical delay/prolongation.No further information provided.
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) 304-22-11 - 10.5mm platform fx stem right.(b)(6) 320-42-00 - 145-deg pe 42mm hum liner +0.(b)(6) 320-01-42 - equinoxe reverse 42mm glenosphere.(b)(6) 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6) 320-20-00 - eq reverse torque defining screw kit.(b)(6) 320-15-05 - eq rev locking screw.(b)(6) 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6) 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6, h11.The following sections were corrected: h6.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 it appears that only 2 screws were used to provide fixation of the glenoid baseplate to the bone.The limited fixation with only two screws likely led to higher stresses and fatigue during in-vivo loading, potentially resulting in the reported loosening.It is unclear if the use of only two screws was intentional due to the patient¿s reported bone quality.However, the reported loosening cannot be confirmed from the information provided.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 baseplate loosening, likely due to a combination of patient-related conditions and improper number of compression screws.However, the loosening cannot be confirmed and any potential contributions from user-related contributing factors to the event cannot be evaluated as no radiographs or clinical information was provided and the device was not available at the time of evaluation.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, 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: 22342830
• Report Number: 1038671-2025-02382
• Device Sequence Number: 12891550
• Product Code: KWS
• UDI-Device Identifier: 10885862186706
• UDI-Public: 10885862186706
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K110708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2025

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: 320-15-06
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown