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

Model Number 1506-10-004

Device Problems Loss of or Failure to Bond (1068); Unintended Movement (3026); Migration (4003)

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

Event Date 09/06/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medical records received (b)(6) 2018.Records indicate patient received an attune tka.No allegations provided of patient injury or product failure, nor report of revision.Doi: (b)(6) 2016.Dor: unknown (left).

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: medical records reviewed.This npi does not meet the definition of a complaint.There is no allegation of deficiency related to the identity, quality, durability, reliability, safety, effectiveness or performance of a verified depuy device after it was released for distribution.There is no report of an adverse event involving a verified depuy device.

• Brand Name: ATTUNE RP TIB BASE SZ 4 CEM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8915591
• MDR Text Key: 155046574
• Report Number: 1818910-2019-101827
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295042587
• UDI-Public: 10603295042587
• 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: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1506-10-004
• Device Catalogue Number: 150610004
• Device Lot Number: 8241618
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 32MM; ATTUNE PS FEM LT SZ 5 CEM; ATTUNE PS RP INSRT SZ 5 8MM; ATTUNE MEDIAL DOME PAT 32MM; ATTUNE PS FEM LT SZ 5 CEM; ATTUNE PS RP INSRT SZ 5 8MM
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR