MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 8 14MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-40-814
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Disorder (2373); No Code Available (3191)
Date of Event	02/14/2018
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
Patient was revised to address loosening of tibial component at cement to implant interface and instability.Cement manufacturer is unknown.Doi: (b)(6) 2015; dor: (b)(6) 2018; left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).(b)(4) used to capture the surgical intervention and medical device removal.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
On (b)(6) 2018, the patient underwent a 2nd left knee revision due to loosening of the tibial component and instability.The surgeon reported the femoral and patellar components were well-fixed, well positioned and not revised.He indicated the tibial component was found to be loose and in relative varus position.The surgeon reported removing loose unstable cement.He indicated instability to the knee prior to the revision.The patient was implanted with depuy revision system and competitor cement.
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.H6 patient code: no code available (3191) was used to capture joint laxity.Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination.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.

• Brand Name: ATTUNE PS FB INSRT SZ 8 14MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9452595
• Report Number: 1818910-2019-122442
• Device Sequence Number: 2146421
• Product Code: JWH
• UDI-Device Identifier: 10603295050407
• UDI-Public: 10603295050407
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2019

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: 08/31/2018
• Device Model Number: 1516-40-814
• Device Catalogue Number: 151640814
• Device Lot Number: 431164
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 11/20/2019; 05/21/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 12/18/2019; 05/22/2020
• 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 38MM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS FEM LT SZ 8 CEM; ATTUNE PS FEM LT SZ 8 CEM; COMPETITOR BONE CEMENT; COMPETITOR BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR