MAUDE Adverse Event Report: DEPUY IRELAND 961610 ATTUNE FB TIB BASE SZ 10 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Catalog Number 150600010

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Not Applicable (3189)

Event Date 06/07/2018

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 was revised to address loosening of tibial tray at the cement to implant interface.Unknown cement manufacturer.Doi: (b)(6) 2017; dor: (b)(6) 2018 right knee.

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.

Manufacturer Narrative

(b)(4).Investigation summary: visual evaluation of the returned device confirms the reported event.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE FB TIB BASE SZ 10 CEM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND 961610 ; loughbeg ringaskiddy; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 961610 ; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7654561
• MDR Text Key: 112861470
• Report Number: 1818910-2018-63597
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295042440
• UDI-Public: 10603295042440
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 150600010
• Device Lot Number: 7791524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR