MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 4 5MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-20-405
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032)
Date of Event	09/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Initial reporter occupation: lawyer.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 received a right attune total knee.The patella was resurfaced and depuy cement was utilized.The primary operative notes were not available at the time of review.Patient received a right knee revision to address pain, stiffness, decreased range of motion, and adhesions.A pre-operative ct scan demonstrated internal rotation of the tibial component concerning for malrotation of the tibial component.Within the revision operative note there is no confirmation of tibial tray mispositioning.The tibial insert, tibial tray, and femoral component were revised.The patellar component was retained.The patient was revised with competitor products.There were no indicated intra-operative complications.Doi: (b)(6) 2017.Doe: (b)(6) 2017 right knee manipulation (captured on linked complaint).Dor: (b)(6) 2018 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 (b)(6) 2015.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 SZ 4 5MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11446557
• Report Number: 1818910-2021-04756
• Device Sequence Number: 19827604
• Product Code: JWH
• UDI-Device Identifier: 10603295045526
• UDI-Public: 10603295045526
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2021

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 Expiration Date: 11/30/2019
• Device Model Number: 1516-20-405
• Device Catalogue Number: 151620405
• Device Lot Number: 602641
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 04/09/2021
• 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 FB INSRT SZ 4 5MM; ATTUNE CR FEM RT SZ 4 CEM; ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL ANAT PAT 35MM; SMARTSET HV BONE CEMENT 40G; SMARTSET HV BONE CEMENT 40G; SMARTSET HV BONE CEMENT 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR