MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ 6 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-30-607
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Pocket Erosion (2013); Synovitis (2094); Ambulation or Postural Difficulties (2544); No Code Available (3191)
Date of Event	10/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(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 received a right primary attune to treat severe end-stage osteoarthritis.The patella was resurfaced and competitor cement x 1 was utilized.The procedure was completed without complications.Patient received a right knee revision to treat pain.Records indicate the tibial tray, femoral component, and tibial insert were revised and the patella was retained.Revision operative notes were not provided.The patient was revised with competitor revision products utilizing competitor cement x 4.The procedure was completed without complications.Doi: (b)(6) 2015.Dor: (b)(6) 2019.Right knee.
Additional Manufacturer Narrative
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.
Event or Problem Description
Patient received a right knee attune revision to treat pain, scar tissue, walking difficulty, flexion contracture, and joint instability.Upon entering the joint, the surgeon determined that the flexion contracture was due to abundant scar tissue adhering to the quadriceps tendon, which required a quadriceps plasty to repair.Abundant scar tissue and synovitis was debrided from the periarticular space.The surgeon identified significant wear debris throughout the joint.The tibial tray was grossly loose at the cement to implant interface and removed.There was a significant tibial bone erosion.The femoral component was well-fixed but revised.Once removed, the surgeon identified distal femoral stress shielding, osteopenia, and condyle bone erosion.The bone defects in the tibia and femur required reconstruction with a stem and cone.The patella was well-fixed, without wear, and retained.The tibial insert was revised.The patient was revised with a competitor construct.The procedure was completed without complications.The surgeon noted that the patient¿s obesity was a contributing factor to the failure of the attune knee.Doi: (b)(6) 2015 dor: (b)(6) 2019 right knee.
Additional Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative:  added: a4, b5, b6, b7, h6 (patient).Corrected: b1, b2, h6 (device).Patient code: no code available (3191) is used to capture tendon injury, joint contracture and joint instability.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE CR RP INSRT SZ 6 7MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10489863
• Report Number: 1818910-2020-19122
• Device Sequence Number: 2816650
• Product Code: NJL
• UDI-Device Identifier: 10603295047889
• UDI-Public: 10603295047889
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: 1516-30-607
• Device Catalogue Number: 151630607
• Device Lot Number: 3449452
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 09/03/2020; 10/05/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 09/17/2020; 10/06/2020
• 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 CR FEM RT SZ 6 NAR CEM; ATTUNE MEDIAL ANAT PAT 35MM; ATTUNE RP TIB BASE SZ 5 CEM; COMPETITOR (STRYKER) BONE CEMENT; COMPETITOR (STRYKER) BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 91