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

Device Problem Naturally Worn (2988)

Patient Problem Osteolysis (2377)

Event Date 03/22/2024

Event Type  Injury  

Manufacturer Narrative

D10: concomitants: 1.5 f.1.5 t.9mm ps poly.32 patella.

Event Description

It was reported that a 67 yo female patient, initial left total knee implanted on an unknown date, underwent a revision procedure on (b)(6) 2024.There was osteolysis present, but no other components loose, so they just switched out the poly for the same size that was originally implanted.The patient was fine, and the case went well.It was just a simple poly swap.There were no surgical delays during the procedure.There was a breakage of device during the procedure.A piece of a trial implant broke off and was removed.The patient was last known to be in stable condition following the event.An x-ray was provided.Explanted device return for analysis is unknown.No device images were provided.No further information trial implant break reported under 1038671-2024-00937.

• Brand Name: UNK
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: matt collins ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19161007
• MDR Text Key: 340790174
• Report Number: 1038671-2024-00941
• Device Sequence Number: 1
• Product Code: JWH
• 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
• Report Date: 04/22/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/22/2024
• 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: 67 YR
• Patient Sex: Female