MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 4 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-50-408
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	09/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 was revised due to chronic effusion, reduced range of motion (+15 to +80 degrees), pain and loosening of the tibial component at the cement to implant interface.Competitor cement was used.She had a previous poly revision by the surgeon on (b)(6) 2016.She had a flexion-extension gap mismatch of 4mm.The attune tibial tray came out with relative ease although sales rep was sure that the surgeon also checked the fixation of the tibial tray when he did the first revision with poly exchange back in 2016.The tray came out with ease and no cement on the back of the tray.Doi: (b)(6) 2015; (b)(6) 2016 (tibial insert); dor: (b)(6) 2020; 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.

• Brand Name: ATTUNE PS RP INSRT SZ 4 8MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10621467
• Report Number: 1818910-2020-21486
• Device Sequence Number: 16782748
• Product Code: NJL
• UDI-Device Identifier: 10603295052319
• UDI-Public: 10603295052319
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1516-50-408
• Device Catalogue Number: 151650408
• Device Lot Number: 8260459
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 11/09/2020
• 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 MEDIAL DOME PAT 35MM.; ATTUNE PS FEM RT SZ 4 NAR CEM.; ATTUNE PS RP INSRT SZ 4 8MM.; ATTUNE RP TIB BASE SZ 2 CEM.; COMPETITOR CEMENT.; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FEM RT SZ 4 NAR CEM; ATTUNE PS RP INSRT SZ 4 8MM; ATTUNE RP TIB BASE SZ 2 CEM; COMPETITOR CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 62