MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE DIST FEM AUG SZ 4 4MM; KNEE FEMORAL ACCESSORY

Model Number	1547-04-001
Medical Device Problem Codes	Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/03/2021
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
It was reported that patient was revised from a competitor tka to an attune revision knee.All of the proper prep and 1mm over ream of the stems was done.The trial sat perfectly and the real implant was constructed to look exactly like the trials.The real femoral construct would not seat fully.It sat 12mm proud and resulted in the knee being misbalanced in flexion and extension.There was a 3 minute surgical delay.
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 lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE DIST FEM AUG SZ 4 4MM
• Common Device Name: KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11529210
• Report Number: 1818910-2021-05561
• Device Sequence Number: 4498525
• Product Code: JWH
• UDI-Device Identifier: 10603295382713
• UDI-Public: 10603295382713
• 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
• Serviced by Third Party (Y/N): Unknown
• 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): 03/03/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1547-04-001
• Device Catalogue Number: 154704001
• Device Lot Number: J6814Z
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 04/19/2021; 04/26/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 04/23/2021; 04/26/2021
• 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 RT SZ 4 CEM; ATTUNE DIST FEM AUG SZ 4 4MM; ATTUNE POS FEM AUG SZ 4 4MM; ATTUNE POS FEM AUG SZ 4 4MM; ATUN FEM SLV M/L 30MM HALF POR; ATUNE PRESSFIT STR STEM14X60MM; ATTUNE CRS FEMORAL RT SZ 4 CEM; ATTUNE DIST FEM AUG SZ 4 4MM; ATTUNE POS FEM AUG SZ 4 4MM; ATTUNE POS FEM AUG SZ 4 4MM; ATUN FEM SLV M/L 30MM HALF POR; ATUNE PRESSFIT STR STEM14X60MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR