MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 3 12MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number 1516-40-312

Device Problem Expiration Date Error (2528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (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

A expired product date was used on the patient.Consigned product, was not sent expired, expired in hospital.Product: 151640312, batch: 589492.Product expired on 07/2019.

Event Description

Additional information received indicated that the surgery time was not extended.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE PS FB INSRT SZ 3 12MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10594183
• MDR Text Key: 208801505
• Report Number: 1818910-2020-21013
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295049692
• UDI-Public: 10603295049692
• Combination Product (y/n): N
• PMA/PMN Number: K111433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1516-40-312
• Device Catalogue Number: 151640312
• Device Lot Number: 589492
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 09/28/2020
• Supplement Dates Manufacturer Received: 10/05/2020; 12/07/2020
• Supplement Dates FDA Received: 10/14/2020; 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1