MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE GLENOID, PEGGED BETA, MEDIUM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	314-02-13
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	10/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient's right shoulder was revised approximately 8 years post op.Patient had failed anatomic shoulder replacement.Severe glenoid loosening due to osteolysis.Patient was last known to be in stable condition following the event.Products not returning: disposed.
Additional Manufacturer Narrative
(d10) concomitant device(s): 310-01-47 - equinoxe, humeral head short, 47mm (beta), (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); 300-01-13 - equinoxe, humeral stem primary, press fit 13mm, (b)(6).
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported may be the result of the glenoid loosening as reported.However, the failure cannot be confirmed as no images or radiographs were provided.Potential contributions of patient or user-related issues to the event cannot be determined from the reported information.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE GLENOID, PEGGED BETA, MEDIUM
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville 32653 ; 3523771140
• MDR Report Key: 20599991
• Report Number: 1038671-2024-04220
• Device Sequence Number: 8804486
• Product Code: HSD
• UDI-Device Identifier: 10885862084514
• UDI-Public: 10885862084514
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025

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 Expiration Date: 05/14/2019
• Device Catalogue Number: 314-02-13
• 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: 10/17/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2014
• 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: Required Intervention; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Male