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 Codes	Adhesion(s) (1695); Muscular Rigidity (1968); Pain (1994); Synovitis (2094)
Date of Event	01/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, the patient underwent a primary right knee replacement using attune implants including a patella and smartset bone cement.On (b)(6) 2018, she experienced a new onset of right knee pain after doing some house cleaning.She states there is a lot of clicking and stiffness as well.Physical therapy is ordered.On (b)(6) 2024, the patient has a right knee bone scan revealing suspected loosening of the femoral and tibial components.On (b)(6) 2024, the patient underwent a right knee revision.Intraoperatively there was scar tissue, extensive synovitis, and the tibial component was confirmed to be loose at the implant to cement interface.The femoral component was well fixed.The patient was revised to competitor implants though the patella was left in situ.Doi: (b)(6) 2018 dor: (b)(6) 2024 right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, 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.G4: 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 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 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21228444
• Report Number: 1818910-2025-01447
• Device Sequence Number: 12837564
• Product Code: MBB
• UDI-Device Identifier: 10603295174288
• UDI-Public: (01)10603295174288(17)190930(10)8647289
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K081163
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,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: 09/30/2019
• Device Catalogue Number: 545035500
• Device Lot Number: 8647289
• 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: 01/30/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female