MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN FEM SLV M/L 35MM HALF POR; KNEE FEMORAL ACCESSORY

Model Number	1511-01-103
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	09/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # = > (b)(4).((b)(4)) used to capture the surgical intervention.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
It was reported that patient is having a left total knee revision with a competitor product implanted.The attune revision trials were all sat perfectly during trialing.During the implantation of the definitive components, the femoral component would not seat fully.It was left proud and created a gap balance issue.Also during impaction of the real femur, the anterior cortex of the femur cracked.The stem was over-reamed by 1mm.The broach and the femoral trial construct sat perfectly.There was a 3 minutes surgical delay.Doe: (b)(6) 2019 left knee.
Additional Manufacturer Narrative
Product complaint (b)(4).Added b1 (product problem) and device code.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.H10 additional narrative: corrected: h6 (patient).H6 patient code: removed the code for surgical intervention.H6 patient code: no code available (3191) was used to capture surgery prolonged, device revision or replacement, and insufficient information.

• Brand Name: ATUN FEM SLV M/L 35MM HALF POR
• Common Device Name: KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9139158
• Report Number: 1818910-2019-106917
• Device Sequence Number: 3123070
• Product Code: JWH
• UDI-Device Identifier: 10603295436508
• UDI-Public: 10603295436508
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K160700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1511-01-103
• Device Catalogue Number: 151101103
• Device Lot Number: J0836A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 09/09/2019; 07/09/2020
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 10/31/2019; 07/09/2020
• 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: 59 YR