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

Model Number 1506-00-005

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); Not Applicable (3189); No Code Available (3191)

Event Date 05/12/2015

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

Received medical records (b)(6) 2018.Medical records report left attune knee revised to address pain and loosening of the tibia component.Based on the operative report account, it was obviously loose, at the cement to bone interface and the cement to implant interface, of the tibia.Femur was well-fixed.Patella had not been resurfaced at primary.Femur, tibia, and insert components revised to competitor products.The cement manufacturer at primary was depuy.Records indicated additional knee revision surgeries after this reported event, but these all involved competitor products.Doi: (b)(6) 2013; dor: (b)(6) 2015; (left knee).

Manufacturer Narrative

Pc-(b)(4).No device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch , a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).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.Added: h6 (no code available (3191) is used to capture the surgical intervention and medical device removal).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.Product complaint # : (b)(4).Investigation summary: no device associated with this report was received for examination.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 5 CEM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7587230
• MDR Text Key: 110622740
• Report Number: 1818910-2018-61767
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295042396
• UDI-Public: 10603295042396
• Combination Product (y/n): N
• PMA/PMN Number: K101433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 1506-00-005
• Device Catalogue Number: 150600005
• Device Lot Number: 3588972
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR