MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 8 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Catalog Number 150600008

Device Problems Loss of or Failure to Bond (1068); Malposition of Device (2616)

Patient Problems Edema (1820); Pain (1994); No Code Available (3191)

Event Date 07/23/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Revision of attune tibial plateau right side because of loosening.There has been no cement adhesion on the cement to metal interface.Doi: 2016.Dor: (b)(6) 2019.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Patient code: no code available ((b)(4)) used to capture the medical device removal.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.Device history lot : null.Device history batch : null.Device history review : null.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 8 CEM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8884638
• MDR Text Key: 154012729
• Report Number: 1818910-2019-100782
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295042426
• UDI-Public: 10603295042426
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 10/04/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 150600008
• Device Lot Number: 8322857
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/23/2019
• Initial Date FDA Received: 08/12/2019
• Supplement Dates Manufacturer Received: 10/21/2019
• Supplement Dates FDA Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE PS FB INSRT SZ 8 6MM; ATTUNE PS FB INSRT SZ 8 6MM
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 112