MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 5 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number 1506-10-005

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Adhesion(s) (1695); Edema (1820); Pain (1994); Synovitis (2094); Not Applicable (3189); No Code Available (3191)

Event Date 05/01/2018

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 pain and tibial loosening at the cement to implant interface.Depuy cement manufacturer was used.Tibia removed by hand with zero cement attached to tibial prosthesis.Doi: unknown; dor: (b)(6) 2018; unknown affected side.

Manufacturer Narrative

Product complaint #:(b)(4).Investigation summary : 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 will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).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.H6 (no code available (3191) is used to capture the surgical intervention and medical device removal).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 right knee revision due to pain, swelling, adhesions, synovitis, and tibial tray loosening at the cement to implant interface.The femoral component and patella component were not revised.Three depuy cement products were used during the primary operation.Doi: (b)(6) 2014, dor: (b)(6) 2018 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.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: ATTUNE RP TIB BASE SZ 5 CEM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7549886
• MDR Text Key: 109423057
• Report Number: 1818910-2018-60736
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295042594
• UDI-Public: 10603295042594
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• 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: 05/01/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: 1506-10-005
• Device Catalogue Number: 150610005
• Device Lot Number: 7920978
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/01/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 06/25/2018; 11/04/2019; 06/30/2020
• Supplement Dates FDA Received: 07/03/2018; 11/08/2019; 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE CR FEM RT SZ 6 CEM; ATTUNE MEDIAL DOME PAT 38MM
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 75