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 Edema (1820); Pain (1994); Synovitis (2094); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 02/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.(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 received a left pfc primary tka to treat pain and swelling secondary to end stage degenerative joint disease.The surgeon notes that the patient has a history of chronic pain and a history of an mcl reconstruction.The patella was resurfaced and depuy cement x 2 was utilized.The procedure was completed without complications.Patient presents s/p left tka with pain, swelling, and walking difficulty.The patient reports losing 30-40 pounds after increasing physical activity.Physical examination identifies joint crepitus and a decrease in rom in flexion and extension.X-rays indicate a tibial tray that has migrated into valgus secondary to loosening.The patient¿s symptoms and pain progressed and on (b)(6) 2018, the patient was referred for revision surgery.Patient received a left knee revision to treat pain, swelling, joint crepitus, walking difficulty, and a decrease on joint rom secondary to loosening and migration of the tibial tray.Upon entering the joint, the surgeon identified and debrided mild effusion and synovitis.The tibial tray loosened and debonded at the cement to implant interface, had subsided into valgus, and was revised.The femoral component and patella were well-fixed, stable, and retained.There was no reported product problem with the explanted tibial insert.The patient was revised with depuy revision components secured with depuy high-viscosity smartset cement.The procedure was completed without complications.Doi: (b)(6) 2015.Dor: (b)(6) 2018; left knee.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary : 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 18 march 2020 0 non-conformances on this lot number.Final micro and sterility tests passed.(b)(4) units released.Lot expiry date: 2016-09.

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

Manufacturer Narrative

Product complaint (b)(4).Investigation summary : 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 (b)(6) 2020.0 non-conformances on this lot number.Final micro and sterility tests passed.(b)(4) units released.Lot expiry date: 2016-09.

• 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
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10385708
• MDR Text Key: 202257247
• Report Number: 1818910-2020-17780
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174288
• UDI-Public: 10603295174288
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: 5450-35-500
• Device Catalogue Number: 545035500
• Device Lot Number: 7995404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MBT CEM KEEL TIB TRAY SZ4; PFC SIGMARP STB TB IN 5 10.0; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIGMA PS CEM FEM SZ5 L; SMARTSET GHV GENTAMICIN 40G; MBT CEM KEEL TIB TRAY SZ4; PFC SIGMARP STB TB IN 5 10.0; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIGMA PS CEM FEM SZ5 L; SMARTSET GHV GENTAMICIN 40G
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male