MAUDE Adverse Event Report:; INSERT, POSTERIOR STABILIZED, SERIES 500, SIZE6 15MM CM

Catalog Number 360-15-506

Device Problems Break (1069); Degraded (1153)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Corrected data: original initial report was submitted as follow up in error.

Event Description

Second revision surgery - the patient had a left total knee arthroplasty (tka) in (b)(6) 1988.A size 6 femoral component, size 6 tibial component, a 6 x 15 posterior stabilized (ps) tibial insert and a 29 mm patella were implanted.On (b)(6) 2005 the patient had a revision of the 6 x 15 tibial insert due to the post of the insert breaking.The patient is back again for a tibial insert and patella revision.The patient had another broken post on the 6 x 15 ps tibial insert and the patella was extremely worn.The patient is morbidly obese, which is why the surgeon felt this insert failed again and why the patella was so worn.The old ps insert was removed and a new 6 x 15 ps constrained tibial insert was implanted.The surgeon went with a constrained insert this time, hoping for better stability.He also changed out the original 29 mm patella that was implanted in 1998 and replaced it with a new 38 mm all poly patella.

• Type of Device: INSERT, POSTERIOR STABILIZED, SERIES 500, SIZE6 15MM CM
• MDR Report Key: 10542667
• MDR Text Key: 207301036
• Report Number: 1644408-2016-00255
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 360-15-506
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention