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

Catalog Number 150600004

Device Problem Loss of or Failure to Bond (1068)

Patient Problems No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)

Event Date 04/30/2018

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

Patient was revised to address tibial loosening at the cement to implant interface.Depuy cement manufacturer.It also states that the original attune fb tibial tray and fb ps insert were replaced with a size 4 attune revision fb cemented tibia base, a 14mm x 50mm revision cemented stem, and a size 6 20mm fb ps tibial insert.There was no remnant of bone cement on the underside of the original tibial base.Doi: (b)(6) 2015; dor: (b)(6) 2018 left knee.

Manufacturer Narrative

(b)(4).Investigation summary: examination 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, a follow-up medwatch will be filed as appropriate.

• 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 ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7548846
• MDR Text Key: 109382972
• Report Number: 1818910-2018-60695
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295042389
• UDI-Public: 10603295042389
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2018

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: 150600004
• Device Lot Number: 8050702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/30/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 05/30/2018
• Supplement Dates FDA Received: 06/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2015
• 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: 77 YR