MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS FB INSRT SZ 5 22MM; KNEE TIBIAL INSERT

Model Number	1517-00-522
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).It has been determined that though the atrial septal defect, patent foramen ovale is a congenital condition the patient had prior to the implantation of depuy implants.The contribution of depuy products / procedure cannot be fully excluded from causing or contributing to the need for corrective surgery for this condition.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 hospitalization, for closing of the foramen ovale.Event is serious and is considered mild.Event is definitely not related to device and is probably related to procedure.Date of implantation: (b)(6) 2020, date of event (onset): (b)(6) 2021, (left knee).Treatment: surgical intervention not related to the study procedure (no products revised).
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.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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 : 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.
Additional Manufacturer Narrative
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE CRS FB INSRT SZ 5 22MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11347958
• Report Number: 1818910-2021-03377
• Device Sequence Number: 19862741
• Product Code: NJL
• UDI-Device Identifier: 10603295054887
• UDI-Public: 10603295054887
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1517-00-522
• Device Catalogue Number: 151700522
• Device Lot Number: HK5422
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 01/28/2021; 04/05/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 02/24/2021; 04/06/2021
• 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 CEMENTED STEM 14X30MM; ATTUNE CEMENTED STEM 14X50MM; ATTUNE CRS FB INSRT SZ 5 22MM; ATTUNE CRS FEMORAL LT SZ 5 CEM; ATUNE CRS FB TIB BASE SZ 4 CEM; COMPETITOR BONE CEMENT (ZIMMER); ATTUNE CEMENTED STEM 14X30MM; ATTUNE CEMENTED STEM 14X50MM; ATTUNE CRS FB INSRT SZ 5 22MM; ATTUNE CRS FEMORAL LT SZ 5 CEM; ATUNE CRS FB TIB BASE SZ 4 CEM; COMPETITOR BONE CEMENT (ZIMMER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 76