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

Catalog Number	151820029
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	07/17/2019
Type of Reportable Event	Serious Injury
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
Pt had bilateral attune tkr 2017 by registrar at (b)(6) hospital.Cr femur 4, fb tibia 3, insert 5mm, 29mm dome patella.Pt fell.Resulting in right patella fracture.This was revised today and 32mm attune dome patella implanted.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.H10 additional narrative: product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.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.Corrective action was not indicated.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 MEDIAL DOME PAT 29MM
• Common Device Name: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8865788
• Report Number: 1818910-2019-100198
• Device Sequence Number: 14138789
• Product Code: JWH
• UDI-Device Identifier: 10603295056669
• UDI-Public: 10603295056669
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 151820029
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 10/04/2019
• 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: 87 YR