MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 8 5MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number 1516-40-805

Device Problem Naturally Worn (2988)

Patient Problems Pain (1994); Injury (2348); No Code Available (3191)

Event Date 03/15/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Attune claim letter threatening litigation received.Claim letter record alleges personal injury occurred as a result of implantation of a defective depuy attune knee device.Doi: (b)(6) 2015; dor: not reported; unknown side.

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 : review of the device history records (dhr) revealed no deviations or nonconformance's associated with this lot (441113).

• Brand Name: ATTUNE PS FB INSRT SZ 8 5MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9417905
• MDR Text Key: 169287356
• Report Number: 1818910-2019-120932
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295050346
• UDI-Public: 10603295050346
• Combination Product (y/n): N
• PMA/PMN Number: K111433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: 1516-40-805
• Device Catalogue Number: 151640805
• Device Lot Number: 441113
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 41MM; ATTUNE MEDIAL DOME PAT 41MM
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR