MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ5 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-20-507
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Loss of Range of Motion (2032); Joint Laxity (4526)
Date of Event	12/28/2020
Type of Reportable Event	Serious Injury
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
Study: (b)(6).Clinical notification received for revision of right total knee to address instability with extensive ligamentous laxity.Date of implantation: (b)(6) 2020, date of revision: (b)(6) 2020, (right knee).Treatment: tibial insert revised.Additional information received: dor (b)(6) 2020: patient received a right knee revision of the tibial insert to treat pain and instability secondary to unspecified internal derangement of the knee.Upon entering the joint, medial compartment scar tissue was debrided.The surgeon notes the knee had intolerable medial laxity with hyperextension.The was no noted wear or dysfunction of the revised tibial insert.The patient received a size 5/14 mm cr fb insert that provided excellent rom and stability.All other knee components were retained.The procedure was completed without complications.Doi: (b)(6) 2020, dor (b)(6) 2020, right knee.
Additional Manufacturer 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.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE CR FB INSRT SZ5 7MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11342270
• Report Number: 1818910-2021-03215
• Device Sequence Number: 3737347
• Product Code: JWH
• UDI-Device Identifier: 10603295045663
• UDI-Public: 10603295045663
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2021

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 Model Number: 1516-20-507
• Device Catalogue Number: 151620507
• Device Lot Number: J6343R
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 03/09/2021
• 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 CR FEM RT SZ 5 NAR CEM; ATTUNE FB TIB BASE SZ 3 CEM; ATTUNE MEDIAL DOME PAT 32MM; COMPETITOR BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 67