MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 4 NAR CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number	1504-10-124
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Advance (2920)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Date of Event	10/20/2020
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
Femoral implant did not seat while cementing and hung up medially.A lateral condyle fracture occurred while impacting.The original implant was removed.The fracture was addressed with lag screws.A new femoral component was implanted without issue.
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.Device history lot : product code 150410124, work order (b)(4) was manufactured on 21/october/2014.(b)(4) parts were manufactured per specification and all raw materials met specification.No scrap associated with this lot.No reprocessing associated with this lot.One deviation found.O nr-0100007 is associated with this lot.This was raised to address the issue of the drawing revision number on the completed inspection sheet for attune ps fem lt sz 6 cem which was at revision g and did not match the drawing revision on the lot traveller which was at revision h at the attune inspection work step.No risk to the product was determined as no product was affected due to this non-conformance.There is no correlation with the complaint failure mode.

• Brand Name: ATTUNE PS FEM LT SZ 4 NAR CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10843010
• Report Number: 1818910-2020-24653
• Device Sequence Number: 17051307
• Product Code: JWH
• UDI-Device Identifier: 10603295041696
• UDI-Public: 10603295041696
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K111433
• 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
• Report Date (Section B): 10/20/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1504-10-124
• Device Catalogue Number: 150410124
• Device Lot Number: 8010284
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 01/26/2021
• 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: UNKNOWN BONE CEMENT; UNKNOWN BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR