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

Catalog Number	314-13-35
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Muscle/Tendon Damage (4532)
Date of Event	02/05/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that this patient's right shoulder was revised approximately 1 year post initial operation.The revision was due to glenoid loosening and rotator cuff failure.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
The reported glenoid loosening may be secondary to instability resulting from the reported rotator cuff failure.However, the failure and potential contributions from manufacturing, patient, or user-related issues to the event cannot be confirmed as the devices were not returned for evaluation and no images or radiographs were provided.D1: corrected d2: corrected d4: corrected g4: corrected h6: corrected health effect, component, and investigation clinical codes.

• Brand Name: EQUINOXE CAGE GLENOID XL, 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21447929
• Report Number: 1038671-2025-01167
• Device Sequence Number: 15283830
• Product Code: KWS
• UDI-Device Identifier: 10885862201034
• UDI-Public: 10885862201034
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2025

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 Expiration Date: 07/25/2023
• Device Catalogue Number: 314-13-35
• 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: 02/05/2025
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 05/16/2025
• 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 Age: 82 YR
• Patient Sex: Male