MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ 6 12MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-30-612
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
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
On (b)(6) 2015: the patient underwent a right total knee arthroplasty.Attune implants were utilized with depuy cement x2.The patella was resurfaced.No intraoperative complications were noted.Medical records (on revision note) indicate a poly exchange occurred post primary to address instability without success but does not provide date of revision for the poly exchange.On (b)(6) 2017 :the patient underwent a revision of the right knee for pain, aseptic loosening of tibial plate, nickel sensitivity, and joint instability attributed to pcl insufficiency.Intraoperatively, the tibial plate was found loose at implant-cement interface.Patella was not revised.All other components were replaced (tibial, insert, femoral) with a non-depuy revision system with non-depuy cement.No complications noted in revision.Doi: (b)(6) 2015.Dor: unknown (insert).Dor: (b)(6) 2017, (primary tibial, unknown revision insert, primary femoral).This complaint captures the unknown revision of the poly insert.The revision of (b)(6) 2017 is captured on (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE CR RP INSRT SZ 6 12MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9540366
• Report Number: 1818910-2020-00200
• Device Sequence Number: 2341397
• Product Code: NJL
• UDI-Device Identifier: 10603295047919
• UDI-Public: 10603295047919
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2019

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 Model Number: 1516-30-612
• Device Catalogue Number: 151630612
• Device Lot Number: 7956512
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 01/29/2020
• 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 CEM.; ATTUNE MEDIAL DOME PAT 38MM.; ATTUNE RP TIB BASE SZ 6 CEM.; DEPUY CMW 2 20G.; DEPUY CMW 2 20G.
• Outcome Attributed to Adverse Event: Required Intervention