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 Fall (1848); Fatigue (1849); Pain (1994); Discomfort (2330); Numbness (2415); Ambulation Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/27/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Dmf# - 13704, trade name gentamicin sulphate, active ingredient(s) gentamicin sulphate, dosage form - powder, strength 1.0g active in our cements.Occupation: lawyer.

Event Description

The patient was revised to address loosening of the tibial and femoral components at unknown interface.Cement manufacturer is unknown.It was also stated that the patient fell.Primary operative notes (b)(6) 2016 indicate the patient received a right total knee replacement due to end stage osteoarthritis.The patella was resurfaced, and depuy cement was utilized x2.The surgery was completed without indication of complication by the surgeon.Devices that were implanted at the (b)(6) 2016 primary are documented on page 1.Office notes mar 2016 ¿ aug 2017 indicate the patient experienced progressive pain, swelling, numbness, feelings of instability and weakness as well as trouble sleeping.The patient received injections from the pain clinic as part of their treatment plan.Ultimately, the surgeon and patient agreed a revision surgery would be required.Bone scan was performed on (b)(6) 2016 reveals intense focal increased activity and uptake of the left knee.Revision operative notes (b)(6) 2017 indicate the patient received a left total knee revision due to pain and possible loosening.The tibial component was noted to be loose, interface not provided.The femoral component and insert were also revised without indication of product deficiency.The patella was left implanted without indication of deficiency.The surgery was completed without indication of complication by the surgeon.Devices that were implanted at the (b)(6) 2017 revision surgery are documented on page 23-24.Radiology report (b)(6) 2017 (post revision surgery) reveals the hardware appears to be intact.There is a remote avulsion fracture of the medial aspect of the medial femoral condyle.There is no indication of treatment related to this avulsion fracture.It is unknown when this fracture occurred, during the removal of previous implants or implantation of revision implants.Therefore, this will not be captured as a separate event.Office notes oct 2017 ¿ mar 2020 indicate the patient continues to experience pain, stiffness, weakness, instability, swelling and leg length discrepancy.The patient also states she has skin discoloration on the medial aspect of her lower leg.It is indicated the surgeon has discussed the potential need for future revision, however, there is no indication an additional revision surgery has taken place.It is indicated, however, that the patient has received pain block injections due to her knee pain.A shoe heel lift was provided to help address the leg length discrepancy.

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 device history record review was conducted for product code 545035500, lot no 8159605, smartset ghv gentamicin 40g as part of the investigation for previous reported event (b)(4).The dhr review showed no non-conformances on this lot number.The final micro and sterility tests were passed.

Manufacturer Narrative

Product complaint # (b)(6).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.H10 additional narrative: added: b5, h6: appropriate term / code not available (e2402) is being utilized to capture extraskeletal ossification (e1626) and limb asymmetry (e2332).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Medical records received.Prior to the primary arthroplasty with depuy components, the patient has had two arthroplasties to address medial and lateral meniscus tears and synovitis.On (b)(6) 2016 the patient had a left total knee arthroplasty due to primary osteoarthritis.The surgeon reported that there were no complications during the procedure.Depuy components, including depuy patella and depuy cement x2 were used during this procedure.(part/lot page 2019 of 9837) it should be noted that the patient had mssa positive result on (b)(6) 2016.No additional invasive treatments were mentioned for the mssa positive result.A bone scan from (b)(6) 2016 nm bone scan noted that the patient had pain.The medial femoral condyle appears to be an avulsion-type fracture on the radiograph suggestive of trauma and/or medial collateral ligament injury.This is consistent with the patient¿s previous two arthroscopies to address medial and lateral meniscus tears prior to placement of depuy components and is not a new development.On (b)(6) 2017, the patient had a left total knee revision to address osteoarthritis and pain.Preoperative radiographs were reported to ¿show small fracture fragments on plain film, some of which could be heterotopic bone¿.During the procedure, the surgeon observed that the tibial tray was easily removed secondary to ¿aseptic loosening¿.No interface was provided.Femoral and insert were revised without mention of an allegation of deficiency.Depuy components, including depuy cement x2, were used during this procedure.(part/lot pages 5618 and 5619 of 9837) medical records from (b)(6) 2018 note that the patient reports having pain from her tibial tuberosity down to approximately 1/3 of her tibia, along with swelling and discoloration (skin).The surgeon observed mild effusion medical records from (b)(6) 2018 note that the patient is experiencing pain, instability, swelling, mild effusion, and weakness in the left knee.(b)(6) 2018 medical records note the patient received injections, nerve block for pain in the knee that did not help.A leg length discrepancy was noted and a lift insert was ordered.

• 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
• MDR Report Key: 10927190
• MDR Text Key: 218946794
• Report Number: 1818910-2020-25760
• 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: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• 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: 8159605
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MBT CEM KEEL TIB TRAY SZ2.5; PFC SIGMARP STB TB IN 3 10.0; PFC*SIGMA/OV DOME PAT 3 PEG,32; SIGMA PS CEM FEM SZ3 L; SMARTSET GHV GENTAMICIN 40G; MBT CEM KEEL TIB TRAY SZ2.5; PFC SIGMARP STB TB IN 3 10.0; PFC*SIGMA/OV DOME PAT 3 PEG,32; SIGMA PS CEM FEM SZ3 L; SMARTSET GHV GENTAMICIN 40G
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR