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); Loss of Range of Motion (2032); Synovitis (2094); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 05/28/2019

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

Right knee rev original surgery done (b)(6) 2015.Patient complained of pain and range of motion concerns.Removed patella, poly and tray.Tibial component was loose, implant to cement.

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

Manufacturer Narrative

Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: corrected: d2b, d3, g1, g5, h6 (patient).Patient code: no code available (3191) is used to capture device revision or replacement.Re-captured patient codes.Removed codes for surgical intervention and loss of range of motion.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

On (b)(6) 2015, the patient received a right knee lateral uka conversion to a primary attune to treat pain secondary to advanced degenerative joint disease.The manufacturer of the explanted uka is unknown.The patella was resurfaced and depuy cement x 2 was utilized.The procedure was completed without complications.On (b)(6) 2019, the patient received a right knee revision to treat pain secondary to patellar adhesions and tibial tray loosening.Upon entering the joint, the surgeon identified and debrided peripatellar adhesions and synovitis.The patella was well-fixed but revised to treat the abundant adhesions and synovitis.The tibial tray was loosened and debonded at the cement to implant interface and revised.There was no reported product problem with the explanted tibial insert.The femoral component was well-fixed and retained.The patient received depuy revision products utilizing depuy cement x 3.The procedure was completed without complications.Doi: (b)(6) 2015.Dor: (b)(6) 2019.Right 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.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
• 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: 8704537
• MDR Text Key: 148189818
• Report Number: 1818910-2019-96119
• 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: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5450-35-500
• Device Catalogue Number: 545035500
• Device Lot Number: 8069452
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL ANAT PAT 35MM; ATTUNE PS FEM RT SZ 5 CEM; ATTUNE PS RP INSRT SZ5 6MM; ATTUNE RP TIB BASE SZ 5 CEM; SMARTSET GHV GENTAMICIN 40G
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR