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

Catalog Number	314-02-03
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580); Aseptic loosening (4883)
Date of Event	07/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this 73 y/o female patient's shoulder was revised approximately 7 years 2 months post op.The patient was revised due to a failed glenoid that came loose.No cement bonding between the bone and implant.Revised from anatomic to reverse shoulder.Patient was last known to be in stable condition following the event.Unable to obtain images or x-rays.Product not returning: discarded.
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): 4804724 300-01-09 - equinoxe, humeral stem primary, press fit 9mm 4028039 300-10-45 - equinoxe replicator plate 4.5mm o/s 4413878 300-20-02 - equinox square torque define screw drive kit 4705576 310-01-44 - equinoxe, humeral head short, 44mm (alpha).
Additional Manufacturer Narrative
H3: the revision reported may have been the result of an insufficient bond between the glenoid component and the bone, which led to aseptic (non-infected) glenoid loosening.However, this cannot be confirmed as the device was not returned for evaluation, and no images or radiographs were provided.
Additional Manufacturer Narrative
"this follow-up report is being submitted to relay additional and/or corrected information.The following sections were corrected: h6.The revision reported may have been the result of an insufficient bond between the glenoid component and the bone, which led to aseptic (non-infected) glenoid loosening.However, this cannot be confirmed as the device was not returned for evaluation, and no images or radiographs were provided.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 ALPHA, 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19992248
• Report Number: 1038671-2024-02864
• Device Sequence Number: 17914130
• Product Code: HSD
• UDI-Device Identifier: 10885862084484
• UDI-Public: 10885862084484
• 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: 2017
• 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,Followup,Followup
• Report Date (Section B): 04/24/2025

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: 11/30/2021
• Device Catalogue Number: 314-02-03
• 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: 07/29/2024
• Supplement Date Received by Manufacturer: 11/05/2024; 04/23/2025
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 12/03/2024; 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2016
• 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
• Patient Age: 73 YR
• Patient Sex: Female