MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM LT SZ 6 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-00-106

Device Problem Noise, Audible (3273)

Patient Problems Adhesion(s) (1695); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Ambulation Difficulties (2544); Joint Laxity (4526)

Event Date 03/27/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Initial reporter occupation: lawyer.Investigation summary: the device associated with this report was not received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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 left knee revision due to tibial tray loosening at the cement to implant interface, arthrofibrosis, and decreased range of motion.Depuy cement was used during the primary operation.Ad 18 jun 2021: litigation record received.Litigation record alleges severe and persistent pain, discomfort, instability, popping and clicking of device, difficulty ambulating, loss of mobility, loss of range of motion, mental anguish, loosening and migration of the tibial component.Doi: (b)(6) 2014, dor: (b)(6) 2018, left knee.

• Brand Name: ATTUNE CR FEM LT SZ 6 CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12124256
• MDR Text Key: 261255734
• Report Number: 1818910-2021-14399
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295041078
• UDI-Public: 10603295041078
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 1504-00-106
• Device Catalogue Number: 150400106
• Device Lot Number: 7791322
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR