MAUDE Adverse Event Report: EXACTECH, INC. LASER CAGE GLENOID S, 8 POST AUG, RIGHT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	314-24-32
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient recalled exercising and lifting weights when they heard a popping sound in their shoulder.On the x-ray, it showed the patient had perforated out the back side of the glenoid.The patient required a competitor's custom baseplate to be made to convert to a reverse total shoulder.Approximately one year and 3 months post the initial right total shoulder arthroplasty, the patient was revised and all components were removed.This consisted of removing the laser cage glenoid, the humeral head and stemless humeral component.The custom baseplate was implanted with a new glenosphere, stem, tray and poly on the humeral side.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.X-rays, images, and ebi data are attached.Products not returning: hospital doesn't release.(b)(6), 314-24-32 - laser cage glenoid s, 8 post aug, right.Concomitants: (b)(6), 300-60-01 - stemless humeral comp laser cage, size 1.(b)(6), 310-62-38 - stemless humeral head 38mm x 13mm x alpha.(b)(6), 319-01-32 - steinmann pin sterile 3.2mm x 178mm.(b)(6), 321-52-07 - 3.2mm drill bit sterile.
Additional Manufacturer Narrative
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 definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was 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: LASER CAGE GLENOID S, 8 POST AUG, RIGHT
• 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: 21148149
• Report Number: 1038671-2025-00223
• Device Sequence Number: 9189780
• Product Code: KWS
• UDI-Device Identifier: 10885862585387
• UDI-Public: 10885862585387
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K212356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/14/2025

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: 314-24-32
• 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: 12/31/2024
• Initial Report FDA Received Date: 01/14/2025
• Date Device Manufactured: 12/29/2022
• 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: 68 YR
• Patient Sex: Female