MAUDE Adverse Event Report: EXACTECH, INC. LASER CAGE GLENOID MEDIUM, ALPHA; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	314-23-03
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	08/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: (b)(6), 310-02-41 - equinoxe, humeral head tall, 41mm (alpha), (b)(6), 314-23-03 - laser cage glenoid medium, alpha, (b)(6), 300-01-09 - equinoxe, humeral stem primary, press fit 9mm, (b)(6), 300-10-15 - equinoxe replicator plate 1.5mm o/s, (b)(6), 300-20-02 - equinox square torque define screw drive kit, (b)(6), 314-23-03 - laser cage glenoid medium, alpha, (b)(6), 321-52-07 - 3.2mm drill bit sterile, (b)(6), 321-52-09 - 3.2mm k-wire, trocar tip, (b)(6), 321-52-10 - 3.2mm k-wire, thd, short 2 k-wires per pack.The revision reported was likely the result of the rotator cuff failure resulting in proximal migration of the humeral side relative to the glenoid and subsequent prosthesis wear of the glenoid.However, rotator cuff failure cannot be conclusively determined from the information provided.Potential contributions of user or patient-related considerations to the event cannot be determined as radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that this patient was revised approximately 9 months post op.Subscap failure so converted anatomic to reverse.Patient was last known to be in stable condition following the event.Unable to obtain images or x-rays.Product was returned for testing.

• Brand Name: LASER CAGE GLENOID MEDIUM, ALPHA
• 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
• MDR Report Key: 22752316
• Report Number: 1038671-2025-02708
• Device Sequence Number: 12924581
• Product Code: KWS
• UDI-Device Identifier: 10885862585295
• UDI-Public: 10885862585295
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/08/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 314-23-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2022
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female