MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 10 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151641006
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.(b)(4).
Event or Problem Description
Attune outsizer kit - was found to have expired implants in the set.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #: (b)(4).Investigation summary: service issue escalated to the loan kit team.No device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.A complaint was reported by a rep regarding an attune outsizer kit stating: "i have just had a call from theatres asking me to come down to look at the attune outsizer kit as they have found expired implants in the set.Fortunately they did not needed size 9 not size 10.I can confirm that the following products in k08 size 10 tibial tray have following expiry dates: 151641006: expires 03/2019, 151641007: expires 05/2019, 151641008: expires 05/2019, 151641010: expires 03/2019, 151641012: expires 06/2019, 151621005: expires 07/2019, 151621006: expires 04/2019, 151621007: expires 02/2019, 151621008: expires 03/2019, 151621010: expires 03/2019, 151621012: expires 03/2019.Just to confirm this did not create a patient issue or endanger a procedure, however i consider it a failing in our processes." this complaint reports a service issue and not a product complaint.The issue has been escalated to and will be further dealt with by the loan kit team.As the parts were not used in a case, there are no associated patient consequences.None of the lot codes were provided; therefore, the expiration dates could not be verified.Further, a worldwide lot specific complaint database search, or device history record (dhr) review could not be conducted.No device associated with this report was received for examination.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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.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: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE PS FB INSRT SZ 10 6MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8459800
• Report Number: 1818910-2019-88818
• Device Sequence Number: 14206766
• Product Code: JWH
• UDI-Device Identifier: 10603295050636
• UDI-Public: 10603295050636
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K111433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 151641006
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1