MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 SMARTSET HV BONE CEMENT 40G; BONE CEMENT : BONE CEMENT

Catalog Number	3092040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	10/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject id: (b)(4).Study no: (b)(6).Clinical adverse event received for: did subject report any new aes or any updates to an existing ae at this evaluation? : yes.Device and procedure (relatedness): device related: no information provided procedure related: no information provided date of event: no information provided date of implant: no information provided date of revision: no information provided device location: knee; no information provided.Treatment/impact: no removal/exchange/revision.Additional event information.Clinical adverse event received for left knee effusion.Device and procedure (relatedness): device related: possibly.Procedure related: possibly.Date of event: 29 oct 2019.Date of implant: (b)(6) 2019.Date of revision: no information provided.Device location: left knee.Treatment/impact: aspiration/drainage; recovered/resolved with no residual effects on (b)(6) 2019.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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 records evaluation (mre) was not perform.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: 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.

• Brand Name: SMARTSET HV BONE CEMENT 40G
• Common Device Name: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool ; UK
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 20332956
• Report Number: 1818910-2024-20413
• Device Sequence Number: 21264478
• Product Code: LOD
• UDI-Device Identifier: 10603295168331
• UDI-Public: (01)10603295168331(17)200229(10)8736672
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033563
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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 Expiration Date: 02/29/2020
• Device Catalogue Number: 3092040
• Device Lot Number: 8736672
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Unknown
• Patient Weight: 116 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American