MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 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 Cyst(s) (1800); Pain (1994); Synovitis (2094); Swelling/ Edema (4577)

Event Date 02/10/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.Dmf# - (b)(4).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

On (b)(6) 2015, the patient received an attune left total knee arthroplasty to address osteoarthritis.A cemented fixed bearing posterior stabilized knee was implanted, using 2 batches of depuy gentamycin bone cement.There were no reported complications.The patient's left knee was revised to address pain, swelling, and aseptic loosening of the femur and the tibial tray implants.The revising surgeon determined that the femur was grossly loose at the cement to bone interface, with the presence of a large cyst beneath the cement mantle.The tibial tray was also grossly loose, but in this case, it was loose at the implant to cement interface--there was no cement bonded to the backside of the tibial tray implant.The cement mantle was removed from the proximal bony tibia without significant bone loss.There was no evidence of effusion or infection, but there was extensive synovitis reported.The patient's primary patella was retained.During implantation of the revision femur construct, a non-displaced femoral fracture was identified, which was treated with two cerclage cables.The patient was placed on limited weight bearing precautions following the revision procedure to further address the bone fracture.Doi: 2016; dor: (b)(6) 2020; 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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : a dhr review was conducted as part of investigation (b)(4).The record review did not reveal any related manufacturing deviations, anomalies or other non-conformances on the provided product and lot combination.Final micro and sterility tests passed.

• Brand Name: SMARTSET GMV 40G US EO
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11841183
• MDR Text Key: 251133537
• Report Number: 1818910-2021-10532
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174295
• UDI-Public: 10603295174295
• Combination Product (y/n): Y
• 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: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: 5450-50-501
• Device Catalogue Number: 545050501
• Device Lot Number: 8068940
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE FB TIB BASE SZ 5 CEM; ATTUNE MEDIAL ANAT PAT 35MM; ATTUNE PS FB INSRT SZ 5 8MM; ATTUNE PS FEM LT SZ 5 CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; ATTUNE FB TIB BASE SZ 5 CEM; ATTUNE MEDIAL ANAT PAT 35MM; ATTUNE PS FB INSRT SZ 5 8MM; ATTUNE PS FEM LT SZ 5 CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR