MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 2 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Catalog Number	150600002
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Malposition of Device (2616); Unintended Movement (3026)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); No Code Available (3191)
Date of Event	11/30/2017
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
The patient underwent a left knee revision due to pain and instability.The surgeon noted the tibial tray was malpositioned, subsided, and loose at the cement to implant interface.There was also bone loss to the femur and tibia.Competitor cement was used during the primary operation.Doi: (b)(6) 2014.Dor: (b)(6) 2017.Left knee.
Additional Manufacturer Narrative
This is a duplicate report of 1818910-2017-52349.1818910-2019-103006 is being retracted as it is a report duplication.1818910-2017-52349 will be kept for investigation purposes.Product complaint(b)(4).

• Brand Name: ATTUNE FB TIB BASE SZ 2 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8959778
• Report Number: 1818910-2019-103006
• Device Sequence Number: 14080941
• Product Code: JWH
• UDI-Device Identifier: 10603295042365
• UDI-Public: 10603295042365
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2019

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 Expiration Date: 11/30/2023
• Device Catalogue Number: 150600002
• Device Lot Number: 7813886
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 10/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANTIBIOTIC SIMPLEX BONE CEMENT; ANTIBIOTIC SIMPLEX BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR