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 Pain (1994); Loss of Range of Motion (2032); No Code Available (3191)

Event Date 03/13/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient called complaining about her left knee.She will be scheduled for a revision on (b)(6) 2018 and she will visit her surgeon on the 20th for follow up.She had her implant on (b)(6) 2014.Patient tripped/fell, pain going up to the hip, on grouching mode because of the pain.Used to exercise three times a day but she can't do it now because of the pain.The knee cap needs to be replaced and the doctor said 90% part of the knee will be replaced.She tried to reached out to the hospital to get the medical records but to no avail.She is a retiree and this has caused her so much stressed.Medical records received on 17 jun 2019 were reviewed for mdr reportability on 31 july 2019.On (b)(6) 2018, the patient underwent a left knee revision due to pain, instability, and tibial tray loosening at the cement to implant interface.There was no cement attached to the tibial tray.The tibial tray and tibial insert were the only products revised.Two depuy cement products were used during the primary operation.Doi: (b)(6) 2014; dor: (b)(6) 2018; left knee.Doi: (b)(6) 2014: dor: (b)(6) 2018, (schedule), (left knee).

Manufacturer Narrative

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.

Manufacturer Narrative

Product complaint # (b)(4).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.Added: h6.Corrected: h6 (retracted code 2032 "range of motion, loss of").If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SMARTSET GHV GENTAMICIN 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 8910274
• MDR Text Key: 154894785
• Report Number: 1818910-2019-101642
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174288
• UDI-Public: 10603295174288
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: 5450-35-500
• Device Catalogue Number: 545035500
• Device Lot Number: 7807538
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR