MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE FB TIB BASE SZ 6 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Catalog Number 150600006

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Not Applicable (3189)

Event Date 05/22/2018

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Revision knee; (b)(6) 2018.Primary implant date (b)(6) 2016.Revision (b)(6) 2018 - long leg alignment would suggest the knee is in varus and tibial loosening evident.Female patient (b)(6).Patient activity levels: low.Relevant patient pre-existing conditions/ comorbidities: (b)(6).

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE FB TIB BASE SZ 6 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 ; 1210 ward avenue; west chester, PA 19380 ; 6103142063
• MDR Report Key: 7611094
• MDR Text Key: 111389320
• Report Number: 1818910-2018-62472
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295042402
• UDI-Public: 10603295042402
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K101433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 150600006
• Device Lot Number: 8017170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/10/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 140