MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 7MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	300-01-07
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitants: 314-02-32 uhmwpe post aug glenoid small, right (b)(6).A10012 - gps implant kit v2 (b)(6).300-10-15 - equinoxe replicator plate 1.5mm o/s (b)(6).300-01-09 - equinoxe, humeral stem primary, press fit 9mm (b)(6).300-20-02 - equinox square torque define screw drive kit (b)(6).310-01-41 - equinoxe, humeral head short, 41mm (alpha) (b)(6).300-01-07 - equinoxe, humeral stem primary, press fit 7mm (b)(6).
Event or Problem Description
As reported, approximately 7 years post initial right total shoulder arthroplasty (tsa), the patient underwent revision due to suspected glenoid loosening.The surgeon planned on converting to reverse; however, while attempting to disassociate the humeral head from the replicator plate, the stem came loose.Everything was removed and replaced by a competitor prosthesis.The event was not related to the breakage of a device and did not lead to a surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Report number: 1038671-2024-04427 multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-04427.The revision reported may be the result of the glenoid loosening and wear as reported.The humeral stem loosening during the revision procedure may have been secondary to forces applied to disassemble modular components or the result of an insufficient bond between the implant and bone.Potential contributions of patient or user-related issues to the event cannot be determined from the reported information as the devices were not available for evaluation and radiographs were not 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, HUMERAL STEM PRIMARY, PRESS FIT 7MM
• 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, INC.; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20724473
• Report Number: 1038671-2024-04428
• Device Sequence Number: 6583110
• Product Code: KWS
• UDI-Device Identifier: 10885862079299
• UDI-Public: 10885862079299
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2025

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 Catalogue Number: 300-01-07
• 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: 10/31/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2017
• 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; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female