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

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Joint Laxity (4526)

Event Date 09/27/2022

Event Type  Injury  

Manufacturer Narrative

Concomitants: 40mm glenosphere; +5mm humeral tray; 40mm +0 liner.Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

It was reported that a male patient, initial right shoulder implanted on (b)(6) 2020, underwent a revision due to loosening.The glenoid components were removed and replaced with a competitor¿s devices.The original stem remains implanted.Patient was last known to be in stable condition following the event.The devices are not available for return as they were sent to pathology.

Manufacturer Narrative

H6: the revision reported was most likely the result of loosening of the glenoid implants secondary to contributions from implant positioning and potential patient conditions.However, this cannot be confirmed as the devices were not available for evaluation and additional clinical information from the initial surgery could not be provided.

• Brand Name: EQUINOXE
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15675169
• MDR Text Key: 302436706
• Report Number: 1038671-2022-01352
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• 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: 12/13/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2022
• Initial Date FDA Received: 10/26/2022
• Supplement Dates Manufacturer Received: 12/07/2022
• Supplement Dates FDA Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Male