MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUNE CRS FB TIB BASE SZ 7 CEM; ATTUNE STEMMABLE TIBIA IMPLANTS : KNEE TIBIAL TRAY

Catalog Number	150640007
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/04/2018
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
The patient was revised to address infection.Doi: unknown; dor: (b)(6) 2018; unknown affected side.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device confirms the reported event.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 IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7218116
• Report Number: 1818910-2018-51991
• Device Sequence Number: 158390
• Product Code: JWH
• UDI-Device Identifier: 10603295042815
• UDI-Public: 10603295042815
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K160700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/04/2018

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: 8556566
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/04/2018
• Supplement Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 01/25/2018
• Supplement Report FDA Received Date: 04/10/2018
• 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