MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 5 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Catalog Number 150610005

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

Patient Problems Pain (1994); Tissue Damage (2104); No Code Available (3191)

Event Date 08/30/2018

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

The patient underwent a right knee revision due to pain, synovitis, effusion, and tibial tray loosening at the cement to implant interface.Unknown cement used during the primary operation.Doi: (b)(6) 2017.Dor: (b)(6) 2018; right knee.

• Brand Name: ATTUNE RP TIB BASE SZ 5 CEM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 8944344
• MDR Text Key: 155951634
• Report Number: 1818910-2019-102492
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295042594
• UDI-Public: 10603295042594
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 150610005
• Device Lot Number: 8478486
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2017
• 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
• Treatment: ATTUNE CR FEM RT SZ 5 CEM; ATTUNE CR RP INSRT SZ 5 6MM
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR