MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 5 14MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-20-514
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/06/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
On (b)(6) 2018: the patient underwent a 2nd right knee revision due to recurrent polyethylene dissociation.The surgeon indicated the liner was found within the suprapatellar pouch.He reported the tibial and femoral components and cement were removed with osteotomes and cement removal tools.He noted the tibial component had loosened between the cement and component interface.The patient was implanted with depuy knee system.Competitor¿s cement was utilized, and there were no complications reported.
Additional Manufacturer Narrative
This is a duplicate report of 1818910-2018-63464.This report is being retracted as it is a report duplication.1818910-2018-63464 will be kept for investigation purposes.

• Brand Name: ATTUNE CR FB INSRT SZ 5 14MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9489077
• Report Number: 1818910-2019-123764
• Device Sequence Number: 234288
• Product Code: JWH
• UDI-Device Identifier: 10603295045700
• UDI-Public: 10603295045700
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1516-20-514
• Device Catalogue Number: 151620514
• Device Lot Number: 7796606
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR