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 Edema (1820); Pain (1994); Local Reaction (2035); Weakness (2145); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 01/20/2020

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 received a right primary attune to treat osteoarthritis, muscle weakness, crepitus, genu varum deformity, and subchondral sclerosis.The patella was resurfaced and depuy cement x 2 was utilized.The procedure was completed without complications.Patient received a right knee revision to treat pain, swelling, stiffness, weakness, and decreased rom secondary to loosening of the tibial tray.Upon entering the joint, the surgeon excised hypertrophic synovium.The surgeon notes the components were well aligned.The tibial tray was loosened and debonded at the cement to implant interface and revised.The femoral component was well-fixed but revised.There was no reported product problem with the explanted tibial insert.The patient received a competitor revision construct utilizing depuy cement x 2.The procedure was completed without complications.Doi: (b)(6) 2017.Dor: (b)(6) 2020.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.

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.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SMARTSET GMV 40G US EO
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd.; blackpool IN ; UK
• MDR Report Key: 10508478
• MDR Text Key: 206149835
• Report Number: 1818910-2020-19654
• 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: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• 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
• Device Lot Number: 8513345
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS FEM RT SZ 7 CEM; ATTUNE PS RP INSRT SZ 7 8MM; ATTUNE RP TIB BASE SZ 8 CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS FEM RT SZ 7 CEM; ATTUNE PS RP INSRT SZ 7 8MM; ATTUNE RP TIB BASE SZ 8 CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 105