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 Loss of Range of Motion (2032); Synovitis (2094); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.Dmf#13704, 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 Description

Patient received a left primary attune tka to treat post-traumatic osteoarthritis.The patella was resurfaced and depuy cement x 2 was utilized.The procedure was completed without complications.Patient received a left knee revision to treat suspected to loosening.Upon entering the joint, synovitis and bony overgrowth was debrided, and tight flexion identified.The femoral component was loose at the cement to bone interface and revised.The tibial tray was loosened and debonded at the cement to implant interface and revised.There was no reported product problem with the revised tibial insert.Patella was retained.The patient was revised with competitor revision components utilizing competitor cement.The procedure was completed without complications.Doi: (b)(6) 2014, dor: (b)(6) 2019, 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 at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: a previous dhr review (b)(4), did not reveal any related manufacturing deviations or anomalies on the reported product code 545035500, lot number 7795159 combination.H10 additional narrative: added: d10 corrected: d3.

• 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: 11659600
• MDR Text Key: 248862276
• Report Number: 1818910-2021-07840
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174288
• UDI-Public: 10603295174288
• Combination Product (y/n): Y
• 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
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• 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: 7795159
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE CR FEM LT SZ 7 CEM.; ATTUNE CR RP INSRT SZ 7 6MM.; ATTUNE MEDIAL DOME PAT 41MM.; ATTUNE RP TIB BASE SZ 8 CEM.; SMARTSET GHV GENTAMICIN 40G.
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR