MAUDE Adverse Event Report: EXACTECH, INC. MOLDED CAGE GLENOID SMALL, ALPHA; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number 314-23-02

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 05/04/2023

Event Type  Injury  

Manufacturer Narrative

Pending investigation.

Event Description

As reported, the patient had an initial right tsa on an unknown date.The patient was revised on (b)(6) 2023.The poly became disassociated from the central cage.The poly and peripheral pegs loosely removed during surgical revision.The cage came out easily with kocher.The patient was revised to competitor devices.There was no reported surgical delay/prolongation.The patient was last known to be in stable condition following the event.

Manufacturer Narrative

The revision reported was likely the result of an insufficient bond between the glenoid pegs and the glenoid bone, which led to aseptic (non-infected) glenoid loosening and prosthesis fracture; however, this cannot be confirmed as the device was not returned for evaluation, and images, radiographs, and product information were not provided.The most probable root cause for the reported event of "prosthesis fracture" is associated with a partial or full-thickness crack in the device materials, either during implantation or sometime after.Do not use if broken device is a screw.Furthermore, the most probable root cause for the event of "loosening - glenoid (primary)" is associated with weakened integration of the primary glenoid component at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.

• Brand Name: MOLDED CAGE GLENOID SMALL, ALPHA
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: 17047962
• MDR Text Key: 316397350
• Report Number: 1038671-2023-01207
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10885862585288
• UDI-Public: 10885862585288
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 314-23-02
• Device Catalogue Number: 314-23-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/08/2023
• Date Manufacturer Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 73 YR
• Patient Sex: Male