MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 35MM; ATTUNE IMPLANT : KNEE PATELLA

Catalog Number 151820035

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

Patient Problems Scarring (2061); Osteolysis (2377); No Code Available (3191)

Event Date 10/20/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Medical records received ad (b)(6) 2019.The patient underwent a left knee revision due to femoral component loosening at an unknown interface.The surgeon noted extensive scarring as well as osteolysis along the posterior medial flange of the femur.Competitor cement was used during the primary operation.Doi: (b)(6) 2014; dor: (b)(6) 2015; left knee.

Manufacturer Narrative

This is a duplicate report of orig mfr.(1818910-2018-55044).1818910-2019-106234 is being retracted as it is a report duplication.Original mfr-( 1818910-2018-55044) will be kept for investigational purposes.

• Brand Name: ATTUNE MEDIAL DOME PAT 35MM
• Type of Device: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9119607
• MDR Text Key: 164171616
• Report Number: 1818910-2019-106234
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295056683
• UDI-Public: 10603295056683
• Combination Product (y/n): N
• PMA/PMN Number: K103756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/04/2019

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
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 151820035
• Device Lot Number: 4380075
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 09/25/2019
• Supplement Dates Manufacturer Received: 10/22/2019
• Supplement Dates FDA Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE FB TIB BASE SZ 3 CEM; COMPETITOR CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR