MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 5 16MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-50-516
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Necrosis (1971); No Code Available (3191)
Date of Event	02/07/2019
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.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.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).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
(b)(6) 2019: the patient underwent a second revision to the left knee secondary to suspected loosening.Non-depuy cement was used.Intraoperatively, the surgeon debrided scar and necrotic tissue; reported the femur was fixed, however easily tapped off with almost all the cement and no bone (cement to bone interface); and the tibia was completely debonded, indicating loosening at the cement to implant and bone to cement interface.The patella was not revised.Pmh: osteoarthritis doi: (b)(6) 2017; dor: (b)(6) 2018 (poly exchange); dor: (b)(6) 2019 (second revision; left knee).

• Brand Name: ATTUNE PS RP INSRT SZ 5 16MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9607211
• Report Number: 1818910-2020-02263
• Device Sequence Number: 13560151
• Product Code: NJL
• UDI-Device Identifier: 10603295052494
• UDI-Public: 10603295052494
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1516-50-516
• Device Catalogue Number: 151650516
• Device Lot Number: 8063911
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 01/20/2020
• Supplement Report FDA Received Date: 03/02/2020
• 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: 56 YR