MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUNE CRS FB TIB BASE SZ 6 CEM; ATTUNE STEMMABLE TIBIA IMPLANTS : KNEE TIBIAL TRAY

Model Number	1506-40-006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Atrial Tachycardia (1731); Unspecified Infection (1930); No Code Available (3191)
Date of Event	02/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
Clinical adverse event received for atrial fibrillation, fast flutter and fast reposed chest infection.Event is serious and is considered moderate event is definitely not related to device and definitely related to procedure.Date of implantation: (b)(6) 2019.Date of event (onset): (b)(6) 2020.(right knee).Treatment: oral medication.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Investigation summary = > no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: ATUNE CRS FB TIB BASE SZ 6 CEM
• Common Device Name: ATTUNE STEMMABLE TIBIA IMPLANTS : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10574226
• Report Number: 1818910-2020-20737
• Device Sequence Number: 3545979
• Product Code: JWH
• UDI-Device Identifier: 10603295042808
• UDI-Public: 10603295042808
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2020

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: 1506-40-006
• Device Catalogue Number: 150640006
• Device Lot Number: 8971037
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 09/23/2020
• 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 CEMENTED STEM 14X50MM; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FB INSRT SZ 7 5MM; ATTUNE PS FEM RT SZ 7 CEM; ATUNE CRS FB TIB BASE SZ 6 CEM; PALACOS R+G 2X40: 66017569/91484799; PALACOS R+G 2X40: 66017569/91484799; PALACOS R+G 2X40: 66017569/91484799; ATTUNE CEMENTED STEM 14X50MM; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FB INSRT SZ 7 5MM; ATTUNE PS FEM RT SZ 7 CEM; ATUNE CRS FB TIB BASE SZ 6 CEM; PALACOS R+G 2X40: 66017569/91484799; PALACOS R+G 2X40: 66017569/91484799; PALACOS R+G 2X40: 66017569/91484799
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Weight: 82