MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 38MM HUMERAL LINER +2.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	EQUINOXE REVERSE 38MM HUMERAL LINER +2.5
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932); Metal Related Pathology (4530)
Date of Event	05/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately seven years post initial tsa, the patient undergoes surgery and a shoulder revision was performed which shows soft tissue inflammation and the presence of metallosis due to the friction of the platform with the glehoesphere, since there was no presence of the liner previously placed in the previous surgery.The cavity was checked to verify if there was presence of the liner in it but the conclusion was reached that it was completely worn (there was no presence of the liner or polyethylene residues).Sales rep was unable to obtain images or x-rays.The device is not available for evaluation.As of note: "prior to this surgery, the doctor had been informed about the recall of the equinoxe system liners.At the time of performing the surgery and seeing its complexity, on the same day we verified the information on the liner with reference to the recall and the doctor was informed that the liner that was placed on the patient was part of the recall.The manufacturing date is 2015 and the patient was placed in 2017".
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Corrected information: h6: health effect/clinical coding, investigation codes.Additional information: h3: the reason for the revision reported cannot be confirmed from the provided information.It may have been the result of positioning of the shoulder components, scapular notching/impingement, and/or patient related factors which may have led to prosthesis wear as reported, disassociation and subsequent migration of the humeral liner and subsequent metal-on-metal articulation between unintended components, or a combination of issues.However, the failure and most likely cause cannot be confirmed as the devices were not available for evaluation and no images or pre-revision radiographs were provided.

• Brand Name: EQUINOXE REVERSE 38MM HUMERAL LINER +2.5
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon
• MDR Report Key: 19472978
• Report Number: 1038671-2024-01779
• Device Sequence Number: 14461924
• Product Code: JWH
• UDI-Device Identifier: 10885862086662
• UDI-Public: 10885862086662
• Combination Product (Y/N): N
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/09/2020
• Device Model Number: EQUINOXE REVERSE 38MM HUMERAL LINER +2.5
• Device Catalogue Number: 320-38-03
• 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: 05/24/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2015
• 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 Sex: Unknown