MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ3 5MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-50-305
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	11/19/2019
Type of Reportable Event	Serious Injury
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 will be filed as appropriate.
Additional 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 or Problem Description
The patient underwent a left knee revision due to pain, discomfort, stiffness, decreased range of motion, and adhesions.The surgeon noted tibial tray mispositioning with slight overhang as well as loosening at the cement to implant interface.The femoral component was loose at the bone to cement interface with slight bone loss of the lateral femoral condyle.The surgeon reported wear on both the tibial tray and tibial insert.The patella component was well-fixed and retained.Depuy cement was used during the primary operation.Doi: (b)(6) 2016; dor: (b)(6) 2019; left knee.

• Brand Name: ATTUNE PS RP INSRT SZ3 5MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9672057
• Report Number: 1818910-2020-04001
• Device Sequence Number: 11459243
• Product Code: NJL
• UDI-Device Identifier: 10603295052142
• UDI-Public: 10603295052142
• 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: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 1516-50-305
• Device Catalogue Number: 151650305
• Device Lot Number: 8089609
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 03/16/2020
• 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: Required Intervention
• Patient Age: 66 YR