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); Pain (1994); Loss of Range of Motion (2032); Joint Laxity (4526); Unspecified Musculoskeletal problem (4535)
Date of Event	06/20/2023
Type of Reportable Event	Serious Injury
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: "jrn combo products: dmf# - (b)(4).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.
Event or Problem Description
Patient had a full revision of left knee to address pain and a popping sensation.During the surgery the patient stated the surgeon found that the tibial base plate was loose and had popped right out.The knee cap (patella) was also out of track.Doi: (b)(6) 2016.Doe: (b)(6) 2023.Affected side: left knee.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.Product description: smartset ghv gentamicin 40g.Product code:.545035500.Lot no: 8178428.Manufacturing date: 2015-09-16.Expiry date: 2017-08-31.Quantity: (b)(4).There were 2 non-conformances on this lot.On review of the applicable ncs none have been identified which would contribute to the complaint event.All qc and microbiology testing met specification.A review of the dhr has confirmed that there were no process issues documented that could contribute to the event described.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: product description: smartset ghv gentamicin 40g.Product code: 545035500.Lot no: 8178428.Manufacturing date: 2015-09-16.Expiry date: 2017-08-31.Quantity: (b)(4).There were 2 non-conformances on this lot.On review of the applicable ncs none.Device history review: a manufacturing record evaluation was performed for the finished device [lot/serial/batch] number, and no non-conformances / manufacturing irregularities were identified.H11 additional narrative: corrected: h4.

• 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 Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 21986465
• Report Number: 1818910-2025-07393
• Device Sequence Number: 8313401
• Product Code: MBB
• UDI-Device Identifier: 10603295174288
• UDI-Public: (01)10603295174288(17)170831(10)8178428
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• 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: Physician
• 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: 08/31/2017
• Device Catalogue Number: 545035500
• Device Lot Number: 8178428
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2015
• 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: 70 YR
• Patient Sex: Male