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 Adhesion(s) (1695); Edema (1820); Erythema (1840); Fall (1848); Muscular Rigidity (1968); Pain (1994); Rash (2033); Swelling (2091); Weakness (2145); Discomfort (2330); Joint Disorder (2373); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191); Joint Contracture (4528); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/17/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient underwent a right sigma tka on (b)(6) 2016.On (b)(6) 2016, patient reporting pain, stiffness, swelling and the right knee ¿not working properly.¿ she was ultimately revised on (b)(6) 2018 for aseptic loosening of the tibial tray at the device-cement interface.

Manufacturer Narrative

Product complaint # (b)(4). (b)(4) is used to capture the medical device removal if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .

Manufacturer Narrative

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.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: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint (b)(4).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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.¿ added: a2 (age) and d11.Corrected h6 (patient).Removed surgical intervention and medical device removal and replaced it with no code available (3191) to capture device revision or replacement.

Event Description

After review of medical records, patient was revised to address chronic pain, swelling, decreased joint rom, stiffness, contracture, weakness, hemarthrosis and arthrofibrosis secondary to aseptic loosening of the tibial tray.Upon entering the joint, the surgeon identified and debrided periarticular scar tissue.The tibial tray was grossly loose and debonded at the cement to implant interface.The femoral component was well-fixed and aligned but revised.There was no reported product problem with the revised tibial insert.The patella was well-fixed and retained.The patient received a competitor revision knee utilizing unknown cement.The procedure was completed without complications.Doi: (b)(6) 2016, dor: (b)(6) 2018, right knee.

Manufacturer Narrative

Product complaint # (b)(4).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:  h6 3191 no code available is now used to only capture patient codes device revision and replacement and hemarthrosis if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: update 03-feb-2021: the investigation was re-opened upon receipt of additional information.No device associated with this report was received for examination.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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.H10 additional narrative:  details for gentamicin component of combination product: dmf# - 13704, trade name ¿ gentamicin sulphate, active ingredient(s) ¿ gentamicin sulphate, dosage form - powder, and strength ¿ 1.0g active in our cements.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

In addition to the previously reported adverse symptoms, the patient was also experiencing the following prior to revision on (b)(6) 2018: fall, warmth, difficulty sleeping, redness, and crepitus.After the revision operation on (b)(6) 2018 where the depuy patellar component was retained with competitor products and unknown cement, the patient went on to experience the following continued adverse symptoms: fall, pain, decreased range of motion, stiffness, edema, warmth, stiffness, redness, and contracture.There is no evidence of a second revision nor invasive intervention involving the right knee.The retained depuy patellar component was previously reported for the continued adverse symptoms.

• 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: 8536250
• MDR Text Key: 142664522
• Report Number: 1818910-2019-91180
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174288
• UDI-Public: 10603295174288
• Combination Product (y/n): N
• PMA/PMN Number: K081163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• 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: 04/01/2021
• 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 2.5 12.5; PFC*SIGMA/OV/DOME PAT 3PEG,35; SIGMA PS CEM FEM SZ2.5 R; SMARTSET GHV GENTAMICIN 40G
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 88