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	Edema (1820); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	06/24/2020
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 left knee revision to treat a flexion contracture of 5 degrees.Upon entering the joint, the surgeon evacuated a small effusion and debrided periarticular synovitis.The tibial tray was grossly loose and easily removed.The surgeon excised cystic lesion from the underlying tibial bone.The femoral component was well fixed but revised.There was no reported product problem with the revised tibial insert.The patella was well fixed and retained.The patient was revised with competitor products.The procedure was completed without complications.Doi: (b)(6) 2014.Doe: (b)(6) 2014.(mua, no revision, captured in (b)(4)).Dor: (b)(6) 2020.Left 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.

• 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
• MDR Report Key: 10785959
• Report Number: 1818910-2020-23920
• Device Sequence Number: 19567631
• Product Code: JWH
• UDI-Device Identifier: 10603295045663
• UDI-Public: 10603295045663
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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
• Report Date (Section B): 10/20/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: 1516-20-507
• Device Catalogue Number: 151620507
• Device Lot Number: 391211
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 12/08/2020
• 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 FB INSRT SZ5 7MM; ATTUNE CR FEM LT SZ 5 NAR CEM; ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL DOME PAT 35MM; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G; ATTUNE CR FB INSRT SZ5 7MM; ATTUNE CR FEM LT SZ 5 NAR CEM; ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL DOME PAT 35MM; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR