MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN FEM SLV M/L 40MM HALF POR; KNEE FEMORAL ACCESSORY

Model Number	1511-01-104
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	02/22/2021
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
Surgeon was using the attune revision under the supervision of cb and mg from dps recon.The system was being used for the second stage of an infected knee arthroplasty.Unintentional outcome: preparation of the implant, approach, bone cuts, trialling etc went as planned.On introduction and impaction of the definitive femoral implant a small crack of the anterior cortex of the femur was detected towards the end of the case.This delayed the case by a further 30minutes whilst 2 x cerclage cables were applied to the femur.This happened at approximate 3pm.I am in the process of chasing the hospital for the lot details of the definitive implants.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATUN FEM SLV M/L 40MM HALF POR
• Common Device Name: KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11444379
• Report Number: 1818910-2021-04696
• Device Sequence Number: 17295864
• Product Code: JWH
• UDI-Device Identifier: 10603295436515
• UDI-Public: 10603295436515
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2021

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: 1511-01-104
• Device Catalogue Number: 151101104
• Device Lot Number: J79D32
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 05/21/2021
• 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