MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number 1506-00-004

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Injury (2348); Not Applicable (3189); No Code Available (3191)

Event Date 07/30/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

Patient being revised for suspected loose tibial tray component.Attune tibial tray was found to be grossly loose with no cement adherence to the back of the implant.There was also pitting on the poly insert.Patient was revised to an attune fb revision tray and stem and a new 20 mm poly insert.Tibial tray loosening at the cement to implant interface.Cement is a depuy product.No further patient information available.Doi: (b)(6) 2015.Dor: (b)(6) 2018.Right knee.

Manufacturer Narrative

(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, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Udi: (b)(4).(b)(4) was used to capture medical device removal.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.H10 additional narrative: corrected: b1, b2, h6 (patient).Patient code: no code available (3191) to capture surgical intervention.

• Brand Name: ATTUNE FB TIB BASE SZ 4 CEM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork, munster ; EI
• MDR Report Key: 7802542
• MDR Text Key: 117780826
• Report Number: 1818910-2018-67311
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295042389
• UDI-Public: 10603295042389
• Combination Product (y/n): N
• PMA/PMN Number: K101433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1506-00-004
• Device Catalogue Number: 150600004
• Device Lot Number: 8120944
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FEM RT SZ 6 NAR CEM
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR