MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FEM POR PS LT SZ 5; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL

Model Number	1504-11-105
Medical Device Problem Codes	Noise, Audible (3273); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Edema (1820); Pain (1994); Anxiety (2328); Discomfort (2330); No Code Available (3191)
Date of Event	08/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (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).Clinical adverse event received for significant left patellar crepitus event is not serious and is considered moderate event is possibly related to device and definitely related to procedure.Date of implantation: (b)(6) 2018; date of event (onset): (b)(6) 2019; (left knee).Product details: component type: attune ps fem lt sz 5 por, catalog number: 150411105, product id/lot number: 8895851.Component type: attune rp tib base sz 5 por, catalog number: 150611005, product id/lot number: 8723506.Component type: attune ps/rp insert sz 5 10mm, catalog number: 151650510, product id/lot number: 8491845.Component type: attune medial dome pat 35mm, catalog number: 151820035, product id/lot number: 8925641.Competitor bone cement utilized at primary.
Additional Manufacturer Narrative
Product complaint (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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: h6 patient code: no code available (3191) used to capture the surgical intervention.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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 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, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.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.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, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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. .

• Brand Name: ATTUNE FEM POR PS LT SZ 5
• Common Device Name: ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9440098
• Report Number: 1818910-2019-121807
• Device Sequence Number: 3282392
• Product Code: NJL
• UDI-Device Identifier: 10603295041900
• UDI-Public: 10603295041900
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K140881
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1504-11-105
• Device Catalogue Number: 150411105
• Device Lot Number: 8895851
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 01/07/2020; 02/18/2020; 03/09/2020; 03/09/2020
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 01/13/2020; 02/21/2020; 03/12/2020; 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS RP INSRT SZ 5 10MM; ATTUNE RP TIB BASE SZ 5 POR; UNKNOWN COMPETITOR BONE CEMENT
• Patient Age: 60 YR
• Patient Weight: 90