MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ 8 5MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151630805
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hypersensitivity/Allergic reaction (1907); Pain (1994); No Code Available (3191)
Date of Event	11/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
Medical records received 17 june 2019 and were reviewed 08 october 2019 for mdr reportability.On (b)(6) 2016, the patient underwent total left knee arthroplasty due degenerative joint disease.The patella was resurfaced.The surgeon reported no intraoperative complications.The patient was implanted with the attune knee system and smartset bone cement x 2.On (b)(6) 2017, the patient underwent a left knee revision due to arthrofibrosis, metal sensitivity, stiffness, and pain.The surgeon indicated a large amount of synovitis was growing over the patella and resected, as well as infrapatellar scarred pad.The patella was reduced.He reported the patient was very tight in flexion.The surgeon reported the removal of the femoral component, offering no complaints about the component.He noted the tibial component was disassociated from the cement mantle.The patient was implanted with a competitor system and smartset bone cement x 3.There were no complications to the procedure.Doi: (b)(6) 2016.Dor: (b)(6) 2017.(lt knee).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > the device associated with this report was not received for examination.Depuy synthes considers the investigation closed at this time.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.

• Brand Name: ATTUNE CR RP INSRT SZ 8 5MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9261928
• Report Number: 1818910-2019-113425
• Device Sequence Number: 2549907
• Product Code: NJL
• UDI-Device Identifier: 10603295048107
• UDI-Public: 10603295048107
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2019

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: 11/30/2020
• Device Catalogue Number: 151630805
• Device Lot Number: 8228376
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 12/04/2019
• 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: 57 YR