MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SMARTSET HIGH PERFORMANCE MV MEDIUM VISCOSITY BONE CEMENT 40G; BONE CEMENT : BONE CEMENT

Catalog Number	3122040
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/18/2023
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 the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: 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
It was reported that a 55-year-old female patient received a second left knee revision to treat persistent global instability.The patient had a previous revision of the tibial insert to treat instability and poly-wear on (b)(6) 2018 ((b)(4)) upon entering the joint, the surgeon noted the tibial tray was stable but mildly loosened at the smart-set cement to implant interface.The femoral component was stable but revised.There was no reported product problem with the revised unknown tibial insert.The patella was well-fixed and retained.The patient received a depuy attune stemmed revision construct secured with competitor cement.The procedure was completed without complications.All available information has been disclosed.No further information was provided.Doi: (b)(6) 2018.Dor (b)(6) 2018 (primary tibial insert captured on (b)(4)).Dor: (b)(6) 2023 (unk insert, femoral, tray, cement).Left knee.
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 HIGH PERFORMANCE MV MEDIUM VISCOSITY BONE CEMENT 40G
• Common Device Name: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21201124
• Report Number: 1818910-2025-01249
• Device Sequence Number: 8534637
• Product Code: LOD
• UDI-Device Identifier: 10603295168379
• UDI-Public: (01)10603295168379(17)190430(10)8532927
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K081155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• 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: 04/30/2019
• Device Catalogue Number: 3122040
• Device Lot Number: 8532927
• 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: 01/08/2025
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2021
• 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: 55 YR
• Patient Sex: Female