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 Code	Unspecified Infection (1930)
Date of Event	09/25/2018
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
Subject id: (b)(6).Study: (b)(4).Clinical adverse event received for rerupture patellar tendon, septic arthritis left knee.Event is serious and is considered moderate.Event is definitely not related to device and is definitely related to procedure.Date of implantation: (b)(6) 2018, date of event (onset): (b)(6) 2018, (left knee).Treatment: left knee revised, with removal of femur, tibial tray, tibial insert, offset adaptor, and tibial stem.Product details: component type: smart set mv bone cement 40g, catalog number: 3122040, lot number: 8661745.Component type: smart set mv bone cement 40g, catalog number: 3122040, lot number: 8661745.Component type: attune revision offset stem adaptor 4 mm, catalog number: 151304000, lot number: 8656523.Component type: attune revision pressfit stem 16 mm x 60 mm, catalog number: 151316060, lot number: hr5221.Component type: attune p/s fem lt sz 7 cem, catalog number: 150410107, lot number: 8309667.Component type: attune revision tibial base fixed bearing size 6 cemented, catalog number: 150640006, lot number: 8505990.Component type: attune ps fb insrt sz 7 14mm, catalog number: 151640714, lot number: 502626.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.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.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 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: 9565593
• Report Number: 1818910-2020-01139
• Device Sequence Number: 19382420
• Product Code: JWH
• UDI-Device Identifier: 10603295042808
• UDI-Public: 10603295042808
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 8505990
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 136