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 Problems Loss of or Failure to Bond (1068); Use of Device Problem (1670); Malposition of Device (2616)

Patient Problem No Code Available (3191)

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.Device was used for treatment, not diagnosis.(b)(4).

Event Description

Patient underwent a right attune tka on (b)(6) 2016 with competitor¿s cement.He then underwent a right revision of the tibial base and insert on (b)(6) 2017 for instability, popping, and loosening of the tibial base at the base-cement interface.After the cement was removed, the surgeon notes that he ¿recut the upper surface of the tibia as the prosthesis was in a little bit of varus.¿ doi: (b)(6) 2016; dor: (b)(6) 2017.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.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, 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.Patient code: no code available (3191) used to capture the medical device removal.

Event Description

Medical records received on 17 jun 2019 were reviewed to identify patient harms/product issues on 13 nov 2019.The patient underwent a right knee revision due to instability and tibial tray malpositioning and loosening at the cement to implant interface.Competitor cement was used during the primary operation.Doi: (b)(6) 2016 dor: (b)(6) 2017 right 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 at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.H6 patient code: no code available (3191) used to capture the joint instability.The previous reported device code use of device problem is being corrected to malposition of device.

• 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
• MDR Report Key: 8465494
• MDR Text Key: 140337416
• Report Number: 1818910-2019-89050
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295042600
• UDI-Public: 10603295042600
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• 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: 03/11/2019

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 Model Number: 1506-10-006
• Device Catalogue Number: 150610006
• Device Lot Number: 8245223
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/11/2019
• Initial Date FDA Received: 03/29/2019
• Supplement Dates Manufacturer Received: 05/02/2019; 11/12/2019; 08/27/2020
• Supplement Dates FDA Received: 05/02/2019; 11/14/2019; 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE CR FEM RT SZ 5 CEM; ATTUNE MEDIAL ANAT PAT 35MM; COMPETITOR BONE CEMENT; COMPETITOR BONE CEMENT
• Patient Outcome(s): Other
• Patient Age: 70 YR