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

Catalog Number 150610006

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); Tissue Damage (2104); No Code Available (3191)

Event Date 09/05/2018

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 right knee revision due to pain, effusions, and tibial tray loosening at the cement to implant interface.Competitor cement was used during the primary operation.Doi: (b)(6) 2016.Dor: (b)(6) 2018; right knee.

Manufacturer Narrative

Product complaint # (b)(4).This is a duplicate report of 1818910-2018-70644.1818910-2019-102636 is being retracted as it is a report duplication.1818910-2018-70644 will be kept for investigational purposes.

• 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: 8949864
• MDR Text Key: 156111556
• Report Number: 1818910-2019-102636
• 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: other
• Type of Report: Initial,Followup
• Report Date: 08/09/2019

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 Catalogue Number: 150610006
• Device Lot Number: 8205316
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/09/2019
• Initial Date FDA Received: 08/30/2019
• Supplement Dates Manufacturer Received: 10/07/2019
• Supplement Dates FDA Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL ANAT PAT 35MM; ATTUNE PS FEM RT SZ 7 CEM; ATTUNE PS RP INSRT SZ7 6MM; COMPETITOR CEMENT; ATTUNE MEDIAL ANAT PAT 35MM; ATTUNE PS FEM RT SZ 7 CEM; ATTUNE PS RP INSRT SZ7 6MM; COMPETITOR CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR