MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 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 Code	Pain (1994)
Date of Event	03/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2014, patient underwent a left total knee arthroplasty due to complaints of chronic left knee pain and was evaluated to have an end-stage osteoarthritis.The patella was resurfaced and depuy cement x2 was utilized.The procedure was completed without complications on (b)(6) 2021, patient underwent a total left knee revision to treat pain secondary to loosening of the tibial tray.Upon entering the joint, the surgeon confirmed loosening of the tibial tray at the cement to implant interface.The tibial tray was grossly loose and debonded at competitor cement to implant interface and revised.The femoral component was well-fixed but revised.There was no reported product problem with the revised tibial insert.The patella was well-fixed and retained.The patient received a competitor revision tibial construct.The procedure was completed without complications.Doi: (b)(6) 2014.Dor: (b)(6) 2021.Left knee.
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 narrative: e3: reporter is a legal attorney.Dmf# - (b)(4).Trade name ¿ (b)(4).Active ingredient(s) ¿ gentamicin sulphate.Dosage form - powder.Strength ¿ 1.0g active in our cements.
Event or Problem Description
Medical records were received: (b)(4) to capture the left knee: doi: (b)(6) 2014: male patient received an attune left tka to treat oa.The patella was resurfaced and depuy cement x2 was utilized.The procedure was completed without complications.Part/lot available on medical record (b)(4) medical record ad (b)(6) 2024 (1) page 4.Please note- the pfc drill bit steinman pin packet and the sigma lcs sterile threaded-headed pins should not be included as an impacted or concomitant product as they are instrumentation utilized during the procedure and not implants.Dor: (b)(6) 2021: a 66-year-old male patient received a total left knee revision to treat pain secondary to the loosening of the tibial tray.Upon entering the joint, the surgeon confirmed the loosening of the tibial tray at the cement-to-implant interface.The tibial tray was grossly loose and debonded at competitor cement to implant interface and revised.The femoral component was well-fixed but revised.There was no reported product problem with the revised tibial insert.The patella was well-fixed and retained.The patient received a competitor revision tibial construct.The procedure was completed without complications.Doi: (b)(6) 2014.Dor: (b)(6) 2021.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 GHV GENTAMICIN 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 FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20656949
• Report Number: 1818910-2024-23464
• Device Sequence Number: 17243127
• Product Code: MBB
• UDI-Device Identifier: 10603295174288
• UDI-Public: (01)10603295174288(17)160530(10)7930957
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K081163
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare 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: 05/30/2016
• Device Catalogue Number: 545035500
• Device Lot Number: 7930957
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2014
• 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: Male