MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 5 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Catalog Number	150410105
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient has concern about attune depuy knee replacement.The patient has been experiencing pain, swelling, effusion, and the feeling like her knee is giving out.The patient is meeting with a surgeon to discuss potential revision.Doi: (b)(6) 2018 affected side: left knee.
Additional Manufacturer Narrative
Product complaint # = > (b)(4) e3: the initial reporter information has been removed for confidentiality/privacy.The initial reporter is a patient 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Product code 150410105, work order (b)(4) attune ps fem lt sz 5 cem was manufactured on 08-sep-2017.(b)(4) parts were manufactured per specification and all raw materials met specification.Scrap: there was one (1) scrap associated with this lot.Scrap code a247 underfill at the gen_labels process step.There is no correlation between this scrap reason and the failure mode of the complaint.Reprocessing: there was no material reprocessing reports (mrr) associated with this lot.Non-conformance: non-conformance: there were three (3) non-conformance associated with this lot.This nr does not pertain to the failure mode of the complaint.No deviations or anomalies have been identified during the review, that would be related to the reported event (b)(4).Expiry date: 31-aug-2027 ifu reference as per bill of material: 090200828 ifu attune fixed bearing.A manufacturing record evaluation was performed for the finished device product number: 150410105 and lot number 8619346, and no non-conformances / manufacturing irregularities related to the malfunction were identified 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: a manufacturing record evaluation was performed for the finished device product number: 150410105 and lot number 8619346, and no non-conformances / manufacturing irregularities related to the malfunction were identified.

• Brand Name: ATTUNE PS FEM LT SZ 5 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18541753
• Report Number: 1818910-2024-01308
• Device Sequence Number: 18087555
• Product Code: JWH
• UDI-Device Identifier: 10603295041627
• UDI-Public: 10603295041627
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2024

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: 150410105
• Device Lot Number: 8619346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2024
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2017
• 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 FB TIB BASE SZ 5 CEM; ATTUNE PS FB INSRT SZ 5 7MM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female