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

Catalog Number	314-13-32
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	01/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported glenoid loosening may be secondary to instability resulting from the reported rotator cuff tear.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.
Additional Manufacturer Narrative
(d10) concomitant devices: 300-30-12 - equinoxe preserve stem 12mm: (b)(6); 310-00-44 - eq 44mm xs offset humeral head: (b)(6); 300-50-15 - eq 1.5mm short rep plate: (b)(6).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.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 the patient underwent an initial total shoulder replacement on the right side.Subsequently, the patient experienced aseptic glenoid loosening.The patient had massive trc tear leading to aseptic glenoid loosening.As a result, approximately 6 years after initial replacement, the patient underwent a right shoulder revision.No further impact to the patient was reported.No other information is available.

• Brand Name: EQUINOXE CAGE GLENOID S, 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21635011
• Report Number: 1038671-2025-01605
• Device Sequence Number: 9511553
• Product Code: KWS
• UDI-Device Identifier: 10885862201003
• UDI-Public: 10885862201003
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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 Expiration Date: 02/16/2020
• Device Catalogue Number: 314-13-32
• 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: 02/22/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 05/14/2025
• Date Device Manufactured: 02/18/2015
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Race: White