MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN FEM SLV M/L 50MM FULL POR; KNEE FEMORAL ACCESSORY

Model Number	1511-01-206
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Date of Event	05/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
It was reported that the patient was having a left total knee revision.The surgeon did all the proper prepping for a stem and sleeve for the femur.The surgeon over reamed 1mm, and broached properly.The trial construct sat perfectly.During impaction of the real femoral component, the patient's femur cracked/ broke.The implant was fully seated by the surgeon, and the surgeon put 2 cables around the femur to stabilize the fracture.The press fit between the trial broach and stem compared the real implant is too much.This causes fractures and endangers the patient.There was a surgical delay of 15 mins.Doe: (b)(6) 2020; left knee.
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 at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: ATUN FEM SLV M/L 50MM FULL POR
• Common Device Name: KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10108905
• Report Number: 1818910-2020-12995
• Device Sequence Number: 16829558
• Product Code: JWH
• UDI-Device Identifier: 10603295419600
• UDI-Public: 10603295419600
• 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
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2020

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: 1511-01-206
• Device Catalogue Number: 151101206
• Device Lot Number: J71D84
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 07/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE CRS FEMORAL LT SZ 8 CEM; ATTUNE DIST FEM AUG SZ 8 4MM; ATTUNE DIST FEM AUG SZ 8 4MM; ATTUNE POS FEM AUG SZ 8 8MM; ATTUNE POS FEM AUG SZ 8 8MM; ATUN FEM SLV M/L 50MM FULL POR; ATUNE PRESSFIT STR STEM22X60MM; ATTUNE CRS FEMORAL LT SZ 8 CEM; ATTUNE DIST FEM AUG SZ 8 4MM; ATTUNE DIST FEM AUG SZ 8 4MM; ATTUNE POS FEM AUG SZ 8 8MM; ATTUNE POS FEM AUG SZ 8 8MM; ATUN FEM SLV M/L 50MM FULL POR; ATUNE PRESSFIT STR STEM22X60MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR