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); Muscular Rigidity (1968); Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	04/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Doi: (b)(6) 2018.Patient received a left primary attune tka to treat severe end-stage arthritis with valgus deformity.The patella was resurfaced and depuy cement x 2 was utilized.The surgeon notes that extensive natural synovitis needed to be debrided before primary implantation.The procedure was completed without complications.Mua: (b)(6) 2018 patient received knee manipulation under anesthesia for unknown reasons.No further information available.Dor (b)(6) 2021.Patient received a right knee revision to treat pain, swelling, stiffness, and instability secondary to loosening of the tibial tray.Upon entering the joint, the surgeon identified and debrided scar tissue.The tibial tray was loose at an unknown interface and revised.The femoral component was revised to accommodate the revision construct.The patella was retained.There was no reported product problem with the revised tibial insert.The patient received a competitor revision construct secured with competitor cement.The procedure was completed without complications.Mua: (b)(6) 2021.Patient received a manipulation under anesthesia for unknown reasons.No further information available.Doi: (b)(6) 2014.Doe: (b)(6) 2018 (mua)- 2nd pc all devices.Dor (b)(6) 2021 (revision tibial tray, insert, and femoral to competitor construct with retained patella).Doe: (b)(6) 2021 (mua) 3rd pc, patella and cement.Right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.The device indicated in the med watch was also reported on (b)(4) as the patient experienced adverse events on different days with the same device.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.

• 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
• Manufacturer (Section G): DEPUY IRELAND - 9616671; loughbeg, ringaskiddy co; cork MA ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13826302
• Report Number: 1818910-2022-04967
• Device Sequence Number: 19949943
• Product Code: JWH
• UDI-Device Identifier: 10603295045663
• UDI-Public: 10603295045663
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• 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): 03/18/2022

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: 12/31/2022
• Device Model Number: 1516-20-507
• Device Catalogue Number: 151620507
• Device Lot Number: HN1650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 03/27/2022
• Initial Report FDA Received Date: 03/19/2022
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE CR FEM LT SZ 5 CEM.; ATTUNE FB TIB BASE SZ 5 CEM.; ATTUNE MEDIAL DOME PAT 38MM.; SMARTSET HV BONE CEMENT 40G.; SMARTSET HV BONE CEMENT 40G.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 94 KG