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

Catalog Number	150440107
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/13/2024
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
It was reported that the patient x-rays show progressive lucent lines and continues to complain of pain.A poly exchange was performed on (b)(6) 2023 and a der was submitted.The femoral component was removed with ease and cement had not adhered to the bone.However the femoral sleeve was ingrown and had to removed utilizing significant effort.The tibial tray was well fixed, however the tibial sleeve only showed fibrous tissue, indicating that it was loose.The patella was also removed quite easily.A full revision off all components was preformed with no delay nor patient harm.No wear was noted and all components were appropriately sized and aligned.Doi: (b)(6) 2022.Dor: (b)(6) 2024.Affected side: left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Information was received indicating that loosening of the femoral component occurred at the bone to cement interface.The customer states cement was well fixed to the device.The bone cement is being reported under report number mwr-27062024-0001663220.Due to this, depuy synthes joint reconstruction considers the device on this report to be not reportable as there is no allegation of deficiency or patient harm, additional follow up is being conducted.Further updates will only be provided if additional information is received that changes the regulatory determination.

• Brand Name: ATTUNE CRS FEMORAL LT SZ 7 CEM
• Common Device Name: KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19615658
• Report Number: 1818910-2024-13957
• Device Sequence Number: 17677373
• Product Code: JWH
• UDI-Device Identifier: 10603295042204
• UDI-Public: (01)10603295042204
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 150440107
• 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: 06/13/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 RP INSRT SZ 7 12MM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE POS FEM AUG SZ 7 4MM; ATTUNE POS FEM AUG SZ 7 8MM; ATUN FEM SLV M/L 40MM HALF POR; ATUN TIB SLV M/L 29MM HALF POR; ATUNE PRESSFIT STR STEM20X60MM; ATUNE PRESSFIT STR STEM20X60MM; ATUNE REV RP TIB BASE SZ 6 CEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female