MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATUN FEM SLV M/L 40MM HALF POR; KNEE FEMORAL ACCESSORY

Model Number	1511-01-104
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hematoma (1884); No Code Available (3191)
Date of Event	03/25/2019
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.(b)(4).
Event or Problem Description
Clinical adverse event received for hematoma and wound infection.Event is serious and is considered moderate.Event is definitely not related to device and definitely related to procedure.(left knee).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device was received.Root cause undetermined.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.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
Patient was treated with a surgical irrigation & debridement, with no revision of products.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device was received.Root cause undetermined.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.
Additional Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: b5 and d6a corrected: b3 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Updated event description: subject id: (b)(6), study no: (b)(6).Clinical adverse event received for: wound infection device related: definitely not procedure related: definitely date of event: 25 mar 2019, date of implant: (b)(6) 2019, date of revision: blank, device location: left.Treatment/impact: hospitalization, injected medication.

• Brand Name: ATUN FEM SLV M/L 40MM HALF POR
• Common Device Name: KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 8524375
• Report Number: 1818910-2019-90933
• Device Sequence Number: 1966011
• Product Code: JWH
• UDI-Device Identifier: 10603295436515
• UDI-Public: 10603295436515
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/27/2019

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: 1511-01-104
• Device Catalogue Number: 151101104
• Device Lot Number: HH9908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 05/16/2019; 05/18/2021; 11/05/2024
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 05/21/2019; 06/04/2021; 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 84 KG