MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ 8 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-30-807
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cyst(s) (1800)
Date of Event	02/13/2020
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
Patient received a bilateral attune total knee.The right patella was resurfaced and unknown cement was utilized.Only partial primary note was illegible.There were no indicated intra-operative complications.The patient underwent a right knee revision to address tibial tray loosening at the cement to implant interface.The surgeon noted the removal of a large anterolateral cyst that went distally for about 3 to 3.5 cm.The tibial tray and tibial insert were revised.The patellar and femoral components were retained.The patient was revised with depuy attune revision components and competitor cement.There were no indicated intra-operative complications.Doi: (b)(6) 20215, dor: (b)(6) 2020 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.The concomitant products were identified to be competitor products used in conjunction with the previously reported adverse event if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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.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 product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE CR RP INSRT SZ 8 7MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11780739
• Report Number: 1818910-2021-09634
• Device Sequence Number: 3894939
• Product Code: NJL
• UDI-Device Identifier: 10603295048121
• UDI-Public: 10603295048121
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2021

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: 04/30/2019
• Device Model Number: 1516-30-807
• Device Catalogue Number: 151630807
• Device Lot Number: 7904825
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 04/22/2021; 06/09/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 05/06/2021; 06/09/2021
• 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 8 CEM; ATTUNE CR FEM RT SZ 8 CEM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE RP TIB BASE SZ 6 CEM; ATTUNE RP TIB BASE SZ 6 CEM; ZIMMER PALACOS BONE CEMENT; ZIMMER PALACOS BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR