MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE POS FEM AUG SZ 6 4MM; KNEE FEMORAL ACCESSORY

Catalog Number	154906001
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
Subject id: (b)(6).Study no: (b)(6).Clinical adverse event received for femoral loosening of the study knee.Event is serious and is considered severe.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2019.Date of revision: (b)(6) 2023.Date of event: 30 aug 2023.(left knee) treatment: revision; femoral component, femoral sleeve, femoral distal augment, femoral posterior augment, and tibial insert were revised.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Dhr review: 1) quantity manufactured: (b)(4).2) date of manufacture: 9/11/2018 3) any anomalies or deviations identified in dhr: no non-conformances / manufacturing irregularities related to the malfunction were identified 4) expiry date: 8/31/2028 5) ifu reference: 090200873 as part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot : dhr review: 1) quantity manufactured: (b)(4).2) date of manufacture: 9/11/2018 3) any anomalies or deviations identified in dhr: no non-conformances / manufacturing irregularities related to the malfunction were identified 4) expiry date: 8/31/2028.5) ifu reference: 090200873.

• Brand Name: ATTUNE POS FEM AUG SZ 6 4MM
• Common Device Name: KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18835914
• Report Number: 1818910-2024-04977
• Device Sequence Number: 7140820
• Product Code: JWH
• UDI-Device Identifier: 10603295383079
• UDI-Public: 10603295383079
• 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: 2023
• 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
• Report Date (Section B): 03/05/2024

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 Catalogue Number: 154906001
• Device Lot Number: J06M93
• 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: 02/21/2024
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE CRS FEMORAL LT SZ 6 CEM; ATTUNE DIST FEM AUG SZ 6 4MM; ATTUNE DIST FEM AUG SZ 6 4MM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE POS FEM AUG SZ 6 4MM; ATTUNE PS RP INSRT SZ 6 7MM; ATUN FEM SLV M/L 35MM HALF POR; ATUN TIB SLV M/L 37MM HALF POR; ATUNE REV RP TIB BASE SZ 5 CEM; COMPETITOR CEMENT; HERAEUS BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 78 KG