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 Pain (1994); No Code Available (3191)

Event Date 06/03/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Initial reporter is attorney.(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

On (b)(6) 2014, the patient underwent a primary left knee arthritis due to osteoarthritis.Two depuy cement products were used during the primary operation.There were no indicated intra-operative complications.On (b)(6) 2016, the patient underwent a left knee revision with tibial insert exchange due to an unknown reason.The revision operative note was not available at the time of review.On (b)(6) 2019, the patient underwent a left knee revision due pain and tibial tray loosening at the cement to implant interface involving two depuy cement products.Competitor products were implanted with competitor cement.There is no indication the depuy patellar component was revised.All remaining products were revised.There were no indicated intra-operative complications.Doi: (b)(6) 2014, dor: (b)(6) 2016 (insert), dor: (b)(6) 2019, left 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 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: dmf# - 13704.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 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 FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 10621985
• MDR Text Key: 209648233
• Report Number: 1818910-2020-21517
• 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: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• 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: 7786784
• 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 32MM; ATTUNE PS FEM LT SZ 4 NAR CEM; ATTUNE PS RP INSRT SZ4 5MM; ATTUNE RP TIB BASE SZ 3 CEM; SMARTSET GMV 40G US EO; ATTUNE MEDIAL DOME PAT 32MM; ATTUNE PS FEM LT SZ 4 NAR CEM; ATTUNE PS RP INSRT SZ4 5MM; ATTUNE RP TIB BASE SZ 3 CEM; SMARTSET GMV 40G US EO
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR