MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE GLENOID, PEGGED ALPHA, MEDIUM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	314-02-03
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Insufficient Information (4580)
Date of Event	11/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient's left anatomic shoulder replacement was revised.Over time the glenoid component failed and became loose.The surgeon carried out a stage one revision removing the existing implants and inserting a cement spacer, with the future plan to carry out a stage two revision and put a reverse shoulder back in.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
D10: (b)(6) 300-10-15 4.5mm replicator plate.(b)(6) 300-11-00 anatomic torque screw.(b)(6) 310-01-44 44mm x 17mm humeral head.(b)(6) 300-101-09 equinoxe, humeral stem primary, press fit 9mm.H3: 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: d4, d6a, and g4 the following sections were corrected: d1, d4, and h6 the revision reported may have been the result of glenoid loosening and wear.The aseptic (non-infected) loosening may have been due to an insufficient bond between the implant and the bone.The observed wear may have been due to orientation of the components, possibly due to a rotator cuff deficiency, leading to eccentric loading and subsequent wear and possible loosening.However, the sequence of event cannot be confirmed, and potential contributions from 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported may have been the result of glenoid loosening and wear.The aseptic (non-infected) loosening may have been due to an insufficient bond between the implant and the bone.The observed wear may have been due to orientation of the components, possibly due to a rotator cuff deficiency, leading to eccentric loading and subsequent wear and possible loosening.However, the sequence of event cannot be confirmed, and potential contributions from 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 ALPHA, MEDIUM
• Common Device Name: PROSTHESIS, SHOULDER, NON-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: 20968563
• Report Number: 1038671-2024-04930
• Device Sequence Number: 8462274
• Product Code: KWT
• UDI-Device Identifier: 10885862084484
• UDI-Public: 10885862084484
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 03/25/2025

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: 07/20/2020
• 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: 11/25/2024
• Supplement Date Received by Manufacturer: 03/20/2025; 03/20/2025
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 03/25/2025; 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female