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

Catalog Number	320-38-10
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Insufficient Information (4580)
Date of Event	08/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: a908209 300-01-13 - equinoxe, humeral stem primary, press fit 13mm, a227948 320-02-38 - rs expanded glenosphere 38mm, +4mm offset, b039570 320-10-00 - equinoxe reverse tray adapter plate tray +0, a809594 320-15-01 - eq rev glenoid plate, a996638 320-15-05 - eq rev locking screw, a953445 320-20-00 - eq reverse torque defining screw kit, a882392 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm, s531490 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm, a896443 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm, a788061 531-78-20 - shouldr gps hex pins kit, 02000124039 a10012 - gps implant kit v2.
Event or Problem Description
It was reported that a 60 yo female patient, initial right shoulder implanted on(b)(6) 2024 , underwent a revision procedure 5 days post due to a dislocation.The humeral stem, adapter tray and liner were exchanged.A constrained liner was implanted.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.No x-rays were provided.The explanted devices are not available for analysis as they were discarded.No device images were provided.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: h6, h11.The following sections were corrected: h6 clinical code.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.A definitive root cause was unable to be determined; however, may have resulted from soft tissue imbalance, patient anatomy, implant positioning, and/or implant selection.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE
• 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, INC.; 2320 nw 66 court; gainesville 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 19996461
• Report Number: 1038671-2024-02877
• Device Sequence Number: 8586085
• Product Code: KWT
• UDI-Device Identifier: 10885862086679
• UDI-Public: 10885862086679
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 12/05/2024

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: 08/22/2026
• Device Catalogue Number: 320-38-10
• 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: 08/08/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2021
• 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: 60 YR
• Patient Sex: Female