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 Insufficient Information (4580)

Event Date 02/04/2023

Event Type  Injury  

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

It was reported that a patient, initial left shoulder implanted on an unknown date, underwent a revision procedure for aseptic loosening of the cemented stem, on an unknown date.The stem and 46 glenosphere were revised.The reported information indicates the initial cemented stem was done 7-10 years ago.There were no surgical delays reported.The patient was last known to be in stable condition following the event.No device returns anticipated due to the hospital policies.

Manufacturer Narrative

After review of additional information received the following sections, have been updated accordingly: h6: the revision reported may have been the result of an insufficient bond between the humeral stem and the bone, which led to aseptic (non-infected) humeral loosening.However, this cannot be confirmed as the devices were not available for evaluation and radiographs were unable to be obtained.

• 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: 16548260
• MDR Text Key: 311369222
• Report Number: 1038671-2023-00445
• 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: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• 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
• Date Manufacturer Received: 05/24/2023
• 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
• Patient Outcome(s): Required Intervention