MAUDE Adverse Event Report: DEPUY CMW - 9610921 SMARTSET GHV GENTAMICIN 40G; BONE CEMENT : BONE CEMENT

Model Number 5450-35-500

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Adhesion(s) (1695); Pain (1994); Fibrosis (3167); No Code Available (3191)

Event Date 02/22/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The patient underwent a right knee revision due to pain, arthrofibrosis, and tibial tray loosening at the cement to implant interface.The surgeon noted some metallosis around the cement of the tibial tray.Two depuy cement products were used during the primary operation.Doi: (b)(6) 2016.Dor: (b)(6) 2018; right knee.

Manufacturer Narrative

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.  patient code: no code available ((b)(4)) used to capture medical if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

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.H10 additional narrative: corrected: h6.Product complaint (b)(4).Investigation summary :no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : update 12-feb-2021: the investigation was re-opened upon receipt of additional information.No device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot : device history reviewed 07 oct 19.2 unrelated non-conformances on this lot number.Final micro and sterility tests passed.(b)(4) units released expiry date: 30-sep-17.Details for gentamicin component of combination product: dmf# - 13704 , trade name ¿ gentamicin sulphate , active ingredient(s) ¿ gentamicin sulphate , dosage form - powder , strength ¿ 1.0g active in our cements.

• Brand Name: SMARTSET GHV GENTAMICIN 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool IN FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 8959979
• MDR Text Key: 156440792
• Report Number: 1818910-2019-103025
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174288
• UDI-Public: 10603295174288
• Combination Product (y/n): N
• PMA/PMN Number: K081163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2017
• Device Model Number: 5450-35-500
• Device Catalogue Number: 545035500
• Device Lot Number: 8169028
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE PS FEM RT SZ 4 CEM; ATTUNE PS RP INSRT SZ 4 8MM; ATTUNE PS FEM RT SZ 4 CEM; ATTUNE PS RP INSRT SZ 4 8MM
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR