MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATUNE CRS FB TIB BASE SZ 7 CEM; ATTUNE STEMMABLE TIBIA IMPLANTS : KNEE TIBIAL TRAY

Catalog Number	150640007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Tissue Damage (2104); Not Applicable (3189)
Date of Event	03/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 to address quadraceps rupture due to fall, urosepsis and infection.Doi: (b)(6) 2018; dor: (b)(6) 2018, left knee.
Additional Manufacturer Narrative
(b)(4).Investigation summary no device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATUNE CRS FB TIB BASE SZ 7 CEM
• Common Device Name: ATTUNE STEMMABLE TIBIA IMPLANTS : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7425255
• Report Number: 1818910-2018-57261
• Device Sequence Number: 19261615
• Product Code: JWH
• UDI-Device Identifier: 10603295042815
• UDI-Public: 10603295042815
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K160700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2018

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 Catalogue Number: 150640007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 04/12/2018
• Supplement Report FDA Received Date: 06/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 125