MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN FEM SLV M/L 45MM HALF POR; KNEE FEMORAL ACCESSORY

Model Number	1511-01-105
Medical Device Problem Codes	Loss of Osseointegration (2408); Migration (4003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	05/15/2020
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
Clinical adverse event received for loose femoral sleeve : migration/loosening - femoral.Event is not serious and is considered moderate.Event is definitely related to device and is definitely not related to procedure.Date of implantation: (b)(6) 2019.Date of event (onset): (b)(6) 2020.(left knee).Treatment: none.
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.

• Brand Name: ATUN FEM SLV M/L 45MM HALF POR
• Common Device Name: KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10109042
• Report Number: 1818910-2020-13000
• Device Sequence Number: 14138440
• Product Code: JWH
• UDI-Device Identifier: 10603295436522
• UDI-Public: 10603295436522
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2020

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: 1511-01-105
• Device Catalogue Number: 151101105
• Device Lot Number: HT2696
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2020
• Supplement Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 07/07/2020
• 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 6 CEM.; ATTUNE CRS RP INSRT SZ 6 8MM.; ATTUNE DIST FEM AUG SZ 6 4MM.; ATTUNE DIST FEM AUG SZ 6 4MM.; ATTUNE POS FEM AUG SZ 6 4MM.; ATTUNE POS FEM AUG SZ 6 4MM.; ATUN FEM SLV M/L 45MM HALF POR.; ATUN PRESSFIT STR STEM12X110MM.; ATUN TIB SLV M/L 37MM HALF POR.; ATUNE PRESSFIT STR STEM14X60MM.; ATUNE REV RP TIB BASE SZ 6 CEM.; SMARTSET GMV 40G US EO.; SMARTSET GMV 40G US EO.; ATTUNE CRS FEMORAL LT SZ 6 CEM.; ATTUNE CRS RP INSRT SZ 6 8MM.; ATTUNE DIST FEM AUG SZ 6 4MM.; ATTUNE DIST FEM AUG SZ 6 4MM.; ATTUNE POS FEM AUG SZ 6 4MM.; ATTUNE POS FEM AUG SZ 6 4MM.; ATUN FEM SLV M/L 45MM HALF POR.; ATUN PRESSFIT STR STEM12X110MM.; ATUN TIB SLV M/L 37MM HALF POR.; ATUNE PRESSFIT STR STEM14X60MM.; ATUNE REV RP TIB BASE SZ 6 CEM.; SMARTSET GMV 40G US EO.; SMARTSET GMV 40G US EO.
• Patient Age: 73 YR
• Patient Weight: 91