MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM LT SZ 7 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number	1504-00-107
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 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 low grade infect of the left knee event is serious and is considered moderate.Event is possibly related to device and is possibly related to procedure.Date of implantation: (b)(6) 2019.Date of event (onset): (b)(6) 2021.(left knee).Treatment: irrigation & debridement with revision insert exchange on (b)(6) 2021.Revision was completed on (b)(6) 2021 as treatment for the worsening of the original infection.Clinical database specifies femoral stem, tibial insert, tibial base, tibial stem, and tibial sleeve were removed.All the primary implants will be coded for infection.The newly revised insert will not be coded as infection as it is not likely to have contributed to the original infection.
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 dhr review for product code - 150400107 / lot - 9030632.1) quantity manufactured:12 2) date of manufacture: 01/19/2019.3) any anomalies or deviations identified in dhr: no anamolies found 4) expiry date: 31/12/2028.5) ifu reference: (b)(4).
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, d10 (concomitant).Corrected: d2b, d4 (primary udi number).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
Additional information received: treatment/impact: hospitalization (initial or prolonged): yes.

• Brand Name: ATTUNE CR FEM LT SZ 7 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15443184
• Report Number: 1818910-2022-18148
• Device Sequence Number: 20229509
• Product Code: JWH
• UDI-Device Identifier: 10603295041085
• UDI-Public: (01)10603295041085(10)9030632
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 09/17/2022

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: 1504-00-107
• Device Catalogue Number: 150400107
• Device Lot Number: 9030632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2022
• Supplement Date Received by Manufacturer: 11/04/2022; 04/16/2026
• Initial Report FDA Received Date: 09/17/2022
• Supplement Report FDA Received Date: 11/06/2022; 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2019
• 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 CR RP INSRT SZ 7 5MM; ATTUNE CR RP INSRT SZ 7 5MM; ATUN TIB SLV M/L 37MM HALF POR; ATUN TIB SLV M/L 37MM HALF POR; ATUNE PRESSFIT STR STEM16X60MM; ATUNE PRESSFIT STR STEM16X60MM; ATUNE REV RP TIB BASE SZ 5 CEM; ATUNE REV RP TIB BASE SZ 5 CEM; SMARTSET GHV GENTAMICIN 20G; SMARTSET GHV GENTAMICIN 20G; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G; UNK ATTUNE KNEE TIBIAL INSERT; UNK ATTUNE KNEE TIBIAL INSERT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 85 KG