MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM RT SZ 4 CEM ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-00-204

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)(4). 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.

• Brand Name: ATTUNE CR FEM RT SZ 4 CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581 ; 6107428552
• MDR Report Key: 11877588
• Report Number: 1818910-2021-11114
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295041191
• UDI-Public: 10603295041191
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 1504-00-204
• Device Catalogue Number: 150400204
• Device Lot Number: 365564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 57 YR
• Patient Weight: 91
• Patient Treatment(s): ATTUNE CR FB INSRT SZ 4 8MM; ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL DOME PAT 38MM
• Patient Outcome(s): Required Intervention