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

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 03/26/2024

Event Type  Injury  

Manufacturer Narrative

H3: pending investigation.

Event Description

It was reported that an unknown patient underwent a revision procedure of their shoulder components.Initial implant date and revision date unknown.The patient was recently revised (after imagining showed clear failure of the polyethylene liner with advanced wear.No other information provided.

• Brand Name: SHOULDER COMPONENTS
• Type of Device: PROSTHESIS, SHOULDER, SEMI-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: matt collins ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19154999
• MDR Text Key: 340795320
• Report Number: 1038671-2024-00932
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2024
• 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