MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 4 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number 1516-20-408

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscular Rigidity (1968); Pain (1994)

Event Date 12/03/2019

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.

Event Description

Subject id: (b)(6).Study: (b)(6).Clinical notification received that patient was experiencing pain and stiffness prior to revision for loosening of the tibial component date of implantation: (b)(6) 2014.(right knee).Treatment: medical intervention/modification (unspecified) surgical revision of study knee, on (b)(6) 2020, with femur, tibial tray, patella and tibial insert all revised.

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.Device history lot: the dhr review revealed: quantity manufactured: 12.Date of manufacture: 20-nov-2012.Any anomalies or deviations identified in dhr: n/a.Expiry date: 31-oct-2017.Ifu reference: (b)(4).

• Brand Name: ATTUNE CR FB INSRT SZ 4 8MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11877592
• MDR Text Key: 260679050
• Report Number: 1818910-2021-11113
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295045557
• UDI-Public: 10603295045557
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

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: 1516-20-408
• Device Catalogue Number: 151620408
• Device Lot Number: 309163
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 05/25/2021
• Supplement Dates Manufacturer Received: 08/03/2021
• Supplement Dates FDA Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE CR FEM RT SZ 4 CEM; ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL DOME PAT 38MM
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 91