MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 6 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-20-607
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	03/27/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 (b)(6) 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 FB INSRT SZ 6 7MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12124192
• Report Number: 1818910-2021-14398
• Device Sequence Number: 3966059
• Product Code: JWH
• UDI-Device Identifier: 10603295045786
• UDI-Public: 10603295045786
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/23/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: 1516-20-607
• Device Catalogue Number: 151620607
• Device Lot Number: 7826479
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR