MAUDE Adverse Event Report: DEPUY CMW - 9610921 SMARTSET GMV 40G US EO; BONE CEMENT : BONE CEMENT

Model Number 5450-50-501

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 10/12/2018

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

Patient was revised to address loosening of the tibial component at cement to implant interface.Cement manufacturer is depuy.During the revision, the tray was found to be grossly loose and there was no cement adherence to the back side of the implant.The team attempted to revise the tibial cut and implant attune fb revision tibial tray.However, the original insert was 14mm thick and by the time the team freshened up the tibia cut , they were handed a 20mm thick attune insert because that was all they had.As a result, the team ended up taking off the femur and doing a full sigma knee revision.It was also noted that the original poly insert was severely pitted.Doi: (b)(6) 2017.Dor: (b)(6) 2018; 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: device history reviewed on 03 jan 19.0 non-conformances on this lot number.Final micro and sterility tests passed.H10 additional narrative: added: h6 (patient) corrected: d2b.Patient code: no code available (3191) is used to capture prolonged surgery and insufficient information.

• Brand Name: SMARTSET GMV 40G US EO
• 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: 9602279
• MDR Text Key: 175413341
• Report Number: 1818910-2020-02142
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174295
• UDI-Public: 10603295174295
• 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,other
• Type of Report: Initial,Followup
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: 5450-50-501
• Device Catalogue Number: 545050501
• Device Lot Number: 8309492
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 38MM; ATTUNE MEDIAL DOME PAT 38MM
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR