MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS RP INSRT SZ 7 6MM; KNEE TIBIAL INSERT

Model Number	1517-10-706
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/15/2021
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.
Event or Problem Description
Subject id: (b)(6).Study: dsj-2016-03.Clinical adverse event received for periprosthetic joint infection, right knee.Event is serious and is considered severe.Event is definitely not related to device and there is a remote possibility it is related to procedure.Date of implantation: (b)(6) 2020.Date of event (onset): (b)(6) 2021.(right knee).Treatment: surgical i&d washout with revision of tibial insert on (b)(6) 2021.Product details: component type: attune revision crs femoral size 7 right cemented; catalog number: 150440207; lot number: j7266u.Component type: attune revision cemented stem 14 mm x 30 mm; catalog number: 151214030; lot number: j8376x.Component type: attune revision tibial base rotating platform size 5 cemented; catalog number: 150660005; lot number: 9572262.Component type: tibial stem - attune revision pressfit stem 10 mm x 60 mm; catalog number: 151310060; lot number: j55j71.Component type: attune revision tibial sleeve porocoat fully coated 37 mm; catalog number: 151111202; lot number: j7205t.Component type: attune revision crs rotating platform insert size 7 6 mm; catalog number: 151710706; lot number: 9334375.Competitor (zimmer) bone cement utilized, 2 batches; component type: palacos r+g 1x40 ; catalog number: 66022663; lot number: 96504853.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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).A manufacturing records evaluation (mre) was not performed.
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: d3, d10 (concomitant), h6.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 RP INSRT SZ 7 6MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12099772
• Report Number: 1818910-2021-14144
• Device Sequence Number: 17197290
• Product Code: NJL
• UDI-Device Identifier: 10603295056126
• UDI-Public: 10603295056126
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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
• Report Date (Section B): 06/11/2021

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: 1517-10-706
• Device Catalogue Number: 151710706
• Device Lot Number: 9334375
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/11/2021
• Supplement Date Received by Manufacturer: 07/11/2021; 02/17/2026
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 07/13/2021; 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE CEMENTED STEM 14X30MM.; ATTUNE CEMENTED STEM 14X30MM.; ATTUNE CRS FEMORAL RT SZ 7 CEM.; ATTUNE CRS FEMORAL RT SZ 7 CEM.; ATTUNE CRS RP INSRT SZ 7 6MM.; ATUN TIB SLV M/L 37MM FULL POR.; ATUN TIB SLV M/L 37MM FULL POR.; ATUNE PRESSFIT STR STEM10X60MM.; ATUNE PRESSFIT STR STEM10X60MM.; ATUNE REV RP TIB BASE SZ 5 CEM.; ATUNE REV RP TIB BASE SZ 5 CEM.; COMPETITOR (ZIMMER) BONE CEMENT.; COMPETITOR (ZIMMER) BONE CEMENT.; COMPETITOR (ZIMMER) BONE CEMENT.; COMPETITOR (ZIMMER) BONE CEMENT.; ATTUNE CEMENTED STEM 14X30MM; ATTUNE CRS FEMORAL RT SZ 7 CEM; ATTUNE CRS RP INSRT SZ 7 6MM; ATUN TIB SLV M/L 37MM FULL POR; ATUNE PRESSFIT STR STEM10X60MM; ATUNE REV RP TIB BASE SZ 5 CEM; COMPETITOR (ZIMMER) BONE CEMENT; COMPETITOR (ZIMMER) BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 84 KG