MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK ATTUNE KNEE PATELLA

Catalog Number UNK ATTUNE KNEE PATELLA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Laxity (4526)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The literature article titled, "does knee prosthesis survivorship improve when implant designs change? findings from the australian orthopaedic association national joint replacement registry" written by peter l.Lewis mbbs, fracs(orth), faortha, stephen e.Graves mbbs, dphil, fracs(orth), faortha, richard n.De steiger mbbs, phd, fracs(orth), faortha, david g.Campbell bmbs, phd, fracs(ortho), faortha, yi peng mmed (epi & stats), alesha hatton b.Med math (hons), and michelle lorimer bsc (maths & compsc) (hons) published by clinical orthopaedics and related research 2020 was reviewed.The article's purpose was to analyze multiple comparisons of the survivorship of different primary knee constructions both depuy and non depuy products.Criteria for survivorship measured by revision marking end of survivorship.Main study focus was revision reasons of joint instability and tibial insert wear.A similar article reviewed under (b)(4) utilizes the same registry with data set from september 1999 to december 2015, but the current article includes a data set from september 1999 to december 2017 (an additional 2 years).Therefore, this complaint captures the possible revision included within the additional 2 years.Also this current article includes patients who received patellar resurfacing and those who did not.Cement manufacturer not identified or discussed.As this data set is an expansion of a previous analysis, quantities of products involved cannot be accurately determined.Depuy products: attune femoral, attune tibial insert, attune tibial tray, attune patella, sigma femoral, sigma tibial insert, sigma tibial tray, sigma patella.Adverse events applicable to all studied products: revisions for poly tibial insert wear.Revisions for joint instability.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: UNK ATTUNE KNEE PATELLA
• Type of Device: PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11177923
• MDR Text Key: 227048700
• Report Number: 1818910-2021-01260
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK ATTUNE KNEE PATELLA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention