MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 6 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number 1506-10-006

Device Problem Loss of or Failure to Bond (1068)

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

Event Date 07/24/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient underwent a left total knee arthroplasty on (b)(6) 2015 secondary to pain and arthritis.Attune implants were used.Non-depuy cement was used.The patella was resurfaced.No intraoperative complications noted.The patient underwent a revision on the left knee on (b)(6) 2018 secondary to pain and suspected loosening.Intraoperatively, the surgeon confirmed loosening of the tibial component at the cement to implant interface.The femoral and patellar components were well-fixed.There were no intraoperative complications noted.Pmh: osteoarthritis, left knee.Doi: (b)(6) 2015 - dor: (b)(6) 2018 (lt knee).

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

• Brand Name: ATTUNE RP TIB BASE SZ 6 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 co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9568788
• MDR Text Key: 174287412
• Report Number: 1818910-2020-01204
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295042600
• UDI-Public: 10603295042600
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1506-10-006
• Device Catalogue Number: 150610006
• Device Lot Number: 8149628
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2015
• 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
• Treatment: ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS FEM LT SZ 6 CEM; ATTUNE PS RP INSRT SZ6 5MM; COMPETITOR'S BONE CEMENT; COMPETITOR'S BONE CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR