MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL ANAT PAT 35MM; ATTUNE IMPLANT : KNEE PATELLA

Model Number 1518-10-035

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

Patient Problems Pain (1994); Osteolysis (2377); No Code Available (3191)

Event Date 07/26/2018

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 received.Claim letter alleged that patient sustained personal injury as a result of implantation of a defective depuy attune knee device.Doi: (b)(6) 2015.Dor; not reported unknown knee.

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.

• Brand Name: ATTUNE MEDIAL ANAT PAT 35MM
• Type of Device: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9426227
• MDR Text Key: 169593695
• Report Number: 1818910-2019-121398
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295056638
• UDI-Public: 10603295056638
• Combination Product (y/n): N
• PMA/PMN Number: K103756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: 1518-10-035
• Device Catalogue Number: 151810035
• Device Lot Number: 8117668
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE PS FEM LT SZ 5 CEM; ATTUNE PS FEM LT SZ 5 CEM
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR