MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 9 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-40-906
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Swelling (2091); Osteolysis (2377); Not Applicable (3189)
Date of Event	01/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.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 will be filed as appropriate.
Event or Problem Description
Received medical records 06/11/2018.Medical records reviewed for mdr reportability.Patient received a right total knee replacement on (b)(6) 2014.On (b)(6) 2014, patient had a washout and wound revision for a small, dime-sized area of superficial wound dehiscence.No implants were revised during that surgery.Knee was then revised on (b)(6) 2016 for pain, swelling, and aseptic loosening of the femur and tibial components.Revising surgeon stated that the cement to bone interface of the femur component was weak, with scar tissue present between the cement and bone.The tibial component was reported loose, but no conclusive information was provided regarding the loosening interface.The patella component was reportedly well-fixed, and not revised.Depuy cement was used during primary.Revising surgeon also identified synovitis and osteolysis, but didn't see any obvious damage to the insert or patella components.Knee was revised to a competitor knee system, with the exception of the retained depuy patella component.Doi: (b)(6) 2014; dor: (b)(6) 2016; (right knee).
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 been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not 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.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Updated 14 may 2020 re-open the complaint was re-opened upon receiving the patient¿s medical record information.The information received did not change the original investigation report 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 PS FB INSRT SZ 9 6MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7767498
• Report Number: 1818910-2018-66224
• Device Sequence Number: 13498071
• Product Code: JWH
• UDI-Device Identifier: 10603295050490
• UDI-Public: 10603295050490
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2018

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: 07/31/2018
• Device Model Number: 1516-40-906
• Device Catalogue Number: 151640906
• Device Lot Number: 399384
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 05/15/2020
• 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: 50 YR