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 Pain (1994); Swelling/ Edema (4577)

Event Date 07/27/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.Component code: appropriate term/code not available (g07002) used to capture no findings available.Dmf# -(b)(4).Trade name: gentamicin sulphate.Active ingredient(s): gentamicin sulphate.Dosage form - powder.Strength 1.0g active in our cements.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.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient reported of pain and suffering.The patient had been living with since (b)(6) of 2011.On that date patient had a total knee replacement surgery in (b)(6) hospital of my left knee performed by surgeon, orthopedics surgeon for (b)(6) at 52 years old, to relieve pain of patient's left knee.Thru the years until (b)(6) of 2021, patient had pain even after the surgery.In (b)(6) of 2022.Patient experienced severe pain in that knee of a different level that resulted in an emergency room visit and subsequently a return visit to dr.On this visit patient was informed that the x-ray showed why the device was now causing severe pain and the records will show even a fracture resulted from the failed implant.A revision surgery was scheduled for (b)(6) of 2022 to correct the problems and relieve the new pain.Based on your findings that will be submitted to you i am requesting $300,00 for the pain and suffering i went thru as well as having to endure another surgery.Records show that previous patients also suffered similar events after the deputy implant was used and due to revision surgery being the remedy your company is liable and the cause of the pain and suffering endured by each patient." doi: april 2011; dor: not indicated; left knee.

• 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
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16617925
• MDR Text Key: 312024505
• Report Number: 1818910-2023-06591
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174295
• UDI-Public: 10603295174295
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K081163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5450-50-501
• Device Catalogue Number: 545050501
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/07/2023
• Initial Date FDA Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 SZ2; PFC SIG RPF CEM FEM SZ 2.5 LT; PFC SIG RPF INS SZ 2.5 12.5MM; PFC*SIGMA/OV/DOME PAT 3PEG,35; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR