MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 3 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-40-306
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994)
Date of Event	09/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (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
Primary operative notes (b)(6) 2016 indicate the patient received a right total knee replacement due to end stage osteoarthritis.The patella was resurfaced, and depuy cement was utilized x2.The surgery was completed without indication of complication by the surgeon.Revision operative notes (b)(6) 2019 indicate the patient received a right total knee revision due to pain and loosening of the tibial component at the cement to implant interface.Upon entering the joint, scar tissue was encountered and removed.All implants with the exception of the patella were revised.The surgery was completed.Doi: (b)(6) 2016, dor: (b)(6) 2019, 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.Device history lot - product/lot information is not available.H10 additional narrative: added: g2 corrected: g1.

• Brand Name: ATTUNE PS FB INSRT SZ 3 6MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11148274
• Report Number: 1818910-2021-00799
• Device Sequence Number: 18984378
• Product Code: JWH
• UDI-Device Identifier: 10603295049654
• UDI-Public: 10603295049654
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2021

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 Model Number: 1516-40-306
• Device Catalogue Number: 151640306
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/04/2021
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 02/12/2021
• 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 FB TIB BASE SZ 3 CEM.; ATTUNE MEDIAL DOME PAT 35MM.; ATTUNE PS FB INSRT SZ 3 6MM.; ATTUNE PS FEM RT SZ 3 CEM.; SMARTSET HV BONE CEMENT 40G.; SMARTSET HV BONE CEMENT 40G.; ATTUNE FB TIB BASE SZ 3 CEM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FB INSRT SZ 3 6MM; ATTUNE PS FEM RT SZ 3 CEM; SMARTSET HV BONE CEMENT 40G; SMARTSET HV BONE CEMENT 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR