MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SMARTSET GHV GENTAMICIN 40G; BONE CEMENT : BONE CEMENT

Catalog Number	545035500
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Pain (1994); Synovitis (2094); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Date of Event	01/01/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Medical records received.Doi: (b)(6) 2016: 65-year-old male patient received a right knee revision of unknown implants to treat tibial tray loosening, metallosis, and osteolysis.The implants revised in this procedure are unknown and will not be captured as a complaint.The patient received a tc3 revision knee, depuy resurfaced patella, and depuy cement x 4.The procedure was completed without complications.Dor: (b)(6) 2023: 73- year-old male patient received a right knee revision to treat progressive pain, swelling, walking difficulty, and stiffness.Upon entering the joint, the surgeon debrided metallosis and synovitis.The surgeon determined the cause of the metallosis was the disassociation of the femoral adaptor and adaptor bolt, causing movement at the adaptor and bolt junction.There was no reported product problem with the revised femoral component.The femoral sleeve and stem were well-fixed and retained.The patella was loosened at an unknown interface secondary to patellar osteolysis and revised.There was no reported product problem with the revised tibial insert.The tibial tray, sleeve, and stem were well-fixed and retained.There was some medial tibial osteolysis that was treated with impaction bone grafting.The patient was revised with competitor cement and depuy tc3 implants.The procedure was completed without complications.Doi: (b)(6) 2016.Dor (b)(6) 2023.Right knee.
Additional Manufacturer Narrative
J&j medtech is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which j&j medtech has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, j&j medtech or its employees that the report constitutes an admission that the device, j&j medtech, or its employees caused or contributed to the potential event described in this report.Additional narrative: "jrn combo products: dmf# - 13704.Trade name ¿ gentamicin sulphate.Active ingredient(s) ¿ gentamicin sulphate.Dosage form - powder.Strength ¿ 1.0g active in our cements." if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: patient states he had knee replacement around 2004, had revision done in 2016 in (b)(6) by surgeon at a hospital.He continued to have issues and in (b)(6) 2023 went to another surgeon in another hospital who replaced what he considered damaged components.He has spoken with attorney.The product was not returned to j&j medtech orthopaedics; however, photos and a video were provided for review.See attachment (b)(4) device video ad (b)(6) 2024, (b)(4) device photo ad (b)(6) 2024 (1), (b)(4) device photo ad (b)(6) 2024 (2), (b)(4) external knee revision (2.53 mb).The photographs attached were reviewed, however they do not represent the reported product.Therefore, the investigation could not draw any conclusions about the reported product due to the insufficient evidence provided.A manufacturing record evaluation was performed for the finished device product code: 545035500 lot number: 8297260, and no non-conformances or manufacturing irregularities were identified.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the photographs provided are not representative of the reported product complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation was performed for the finished device product code: 545035500 lot number: 8297260, and no non-conformances or manufacturing irregularities were identified.Added: d10 concomitant.

• Brand Name: SMARTSET GHV GENTAMICIN 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 21987291
• Report Number: 1818910-2025-07431
• Device Sequence Number: 15531863
• Product Code: MBB
• UDI-Device Identifier: 10603295174288
• UDI-Public: (01)10603295174288(17)180331(10)8297260
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K081163
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 545035500
• Device Lot Number: 8297260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2016
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LCS CRUC M/B PAT REPLC GVF LG+.; MBT REVISION CEM TIB TRAY SZ 5.; PFC*SIGMA TC3 FEM RT SZ5.; SIG FEM ADAP +2/-2 OFFSET BOLT.; SIGMA FEM ADAPTER 5 DEGREE.; SMARTSET GHV GENTAMICIN 40G.; SMARTSET GHV GENTAMICIN 40G.; SMARTSET GHV GENTAMICIN 40G.; TC3 RP TIBIAL INSERT S5, 20.0.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male