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

Model Number	EQUINOXE REVERSE 38MM HUMERAL LINER +2.5
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
This 76 year old, male patient presented to the hospital with a dislocated right shoulder.The patient consented to revision surgery, having previously had a total shoulder replacement for trauma.The surgeon discovered that the trauma stem was retroverted more than usual, which explained the dislocation.Microbiology samples were taken and the 0mm humeral tray and 0mm humeral liner were removed and replaced with a new 0mm humeral tray and a 5mm humeral liner.The surgeon was unable to reattach the greater trochanter, so left it.The shoulder was stable and secure.There was no reported breakage of devices or surgical delay/prolongation.The patient was last known to be instable condition following the event.No other patient information/medical history reported.The devices are not returning as the hospital will not allow implants to be desterilized for return.
Additional Manufacturer Narrative
Pending evaluation.320-10-00, 7318926 - equinoxe reverse tray adapter plate tray +0.
Additional Manufacturer Narrative
Section h10: (h3)based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the surgical event cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: g2, h6, h11.No device was returned for evaluation; the reported event was confirmed by review of radiograph images provided.The review identified that the joint appears to be dislocated.Additionally, the proximal portion appears to be fractured.This is consistent with the reported information of a prior trauma and likely contributed to the dislocation.Operative notes and/or medical records were not provided for review of usage/ technique.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, may have resulted from the patient's fractured humerus from a previous trauma.Dislocation is a known risk, as outlined in the ifu.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
The following section has been added: h6 - f code.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE REVERSE 38MM HUMERAL LINER +2.5
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15171797
• Report Number: 1038671-2022-00881
• Device Sequence Number: 20114089
• Product Code: KWT
• UDI-Device Identifier: 10885862086662
• UDI-Public: 10885862086662
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/15/2025

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: 10/18/2025
• 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
• Distributor Facility Aware Date: 07/18/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2022
• Supplement Date Received by Manufacturer: 08/15/2022; 09/05/2025; 09/05/2025
• Initial Report FDA Received Date: 08/04/2022
• Supplement Report FDA Received Date: 09/02/2022; 09/08/2025; 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2020
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male