MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE CR RP INSRT SZ4 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151630407
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Sticker sheet provided with attune implants indicating patient underwent a right tka on (b)(6) 2017.She then underwent a revision on (b)(6) 2018 for pain and feelings of instability when walking or rising from a chair.The surgeon notes no signs of infection, wear or loosening during operation.Poly insert was switched out from a 7mm to 12mm achieving improved stability.Doi: (b)(6) 2017; dor: (b)(6) 2018; (insert only).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE CR RP INSRT SZ4 7MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8465517
• Report Number: 1818910-2019-89056
• Device Sequence Number: 16192558
• Product Code: NJL
• UDI-Device Identifier: 10603295047643
• UDI-Public: 10603295047643
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 151630407
• Device Lot Number: 8210473
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR