MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL ANAT PAT 29MM; ATTUNE IMPLANT : KNEE PATELLA

Catalog Number	151810029
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Pain (1994); Osteolysis (2377); No Code Available (3191)
Date of Event	05/21/2018
Type of Reportable Event	Serious Injury
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
Medical records received 17 jun 2019 were reviewed 07 oct 2019 for reportability purposes.On (b)(6) 2015 the patient underwent a left knee arthroplasty due to left knee end-stage osteoarthritis.Attune knee implants were placed along with two smartset cements.The surgeon reported no intraoperative complications.On (b)(6) 2018, the patient underwent a left knee revision due to pain, tibial tray loosening at the cement to implant interface, and cement to bone interface.The surgeon noted that there was early osteolysis and minimal effusion.The patella and femoral component were revised even though they were noted to be well fixed.Competitor components were placed during the revision.The surgeon reported no intraoperative complications.Doi: (b)(6) 2015; dor: (b)(6) 2018; left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > the device associated with this report was not 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 MEDIAL ANAT PAT 29MM
• Common Device Name: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9266405
• Report Number: 1818910-2019-113361
• Device Sequence Number: 2615786
• Product Code: JWH
• UDI-Device Identifier: 10603295056614
• UDI-Public: 10603295056614
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K103756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2019

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: 11/30/2017
• Device Catalogue Number: 151810029
• Device Lot Number: 3520398
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 12/03/2019
• 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: Required Intervention
• Patient Age: 60 YR