MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ5 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number 1516-20-507

Device Problem Naturally Worn (2988)

Patient Problems Edema (1820); Pain (1994); Injury (2348); Osteolysis (2377); No Code Available (3191)

Event Date 06/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.(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

Attune claim letter received.Litigation record alleges personal injury as a direct result of defective manufacturing depuy attune knee device implanted.Doi: (b)(6) 2015; dor: unknown; 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.

• Brand Name: ATTUNE CR FB INSRT SZ5 7MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9547419
• MDR Text Key: 173901880
• Report Number: 1818910-2020-00403
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295045663
• UDI-Public: 10603295045663
• Combination Product (y/n): N
• PMA/PMN Number: K101433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 1516-20-507
• Device Catalogue Number: 151620507
• Device Lot Number: 630367
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR