MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN FEM SLV M/L 30MM HALF POR; KNEE FEMORAL ACCESSORY

Model Number	1511-01-102
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	06/12/2020
Type of Reportable Event	Malfunction
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
The patient was prepped for stems and sleeves on both the femur and tibia.The surgeon over-reamed for the stems by 1 mm and prepped for sleeves.The trial construct sat perfectly.The real femoral construct would not seat fully.It sat proud about 4 mm.The surgeon removed the femoral component and cleaned the cement off its backside and off the patient.The surgeon checked his femoral cuts and seated the broach again.Then he tried the real construct again and it sat properly.New cement was mixed and the real construct was implanted.It is unknown why the construct did not sit properly the first time.Thought that the pressfit for this construct is too much.Cleaning, prepping and re-cementing cost the surgeon a lot of time in the or.Doe: (b)(6) 2020 right knee.
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.Removed not applicable code and replaced with no code available (3191) for prolonged surgery and insufficient information.

• Brand Name: ATUN FEM SLV M/L 30MM HALF POR
• Common Device Name: KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10202442
• Report Number: 1818910-2020-14553
• Device Sequence Number: 1074021
• Product Code: JWH
• UDI-Device Identifier: 10603295436492
• UDI-Public: 10603295436492
• 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
• Report Date (Section B): 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1511-01-102
• Device Catalogue Number: 151101102
• Device Lot Number: J6781X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 07/30/2020
• 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 RT SZ 5 CEM; ATTUNE POS FEM AUG SZ 5 8MM; ATTUNE POS FEM AUG SZ 5 8MM; ATUN FEM SLV M/L 30MM HALF POR; ATUNE PRESSFIT STR STEM12X60MM
• Patient Age: 74 YR