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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 07/07/2022

Event Type  Injury  

Event 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.

Manufacturer Narrative

Pending evaluation.320-10-00, 7318926 - equinoxe reverse tray adapter plate tray +0.

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.

• Brand Name: EQUINOXE REVERSE 38MM HUMERAL LINER +2.5
• Type of Device: 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
• MDR Text Key: 297314094
• Report Number: 1038671-2022-00881
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086662
• UDI-Public: 10885862086662
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male