MAUDE Adverse Event Report: DEPUY CMW - 9610921 SMARTSET GHV GENTAMICIN 40G; BONE CEMENT : BONE CEMENT

Model Number 5450-35-500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 08/25/2020

Event Type  Injury  

Manufacturer Narrative

(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

The patient was revised to address pain.Doi: unknown, dor: (b)(6) 2020, unknown affected 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.Details for gentamicin component of combination product: 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 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: 10690085
• MDR Text Key: 211677004
• Report Number: 1818910-2020-22562
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/01/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 5450-35-500
• Device Catalogue Number: 545035500
• Device Lot Number: 3299567
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/16/2020
• Supplement Dates Manufacturer Received: 11/17/2020; 11/11/2020
• Supplement Dates FDA Received: 11/17/2020; 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MBT CEM KEEL TIB TRAY SZ3; PFC SIGMARP STB TB IN 3 10.0; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIGMA PS CEM FEM SZ3 R; MBT CEM KEEL TIB TRAY SZ3; PFC SIGMARP STB TB IN 3 10.0; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIGMA PS CEM FEM SZ3 R
• Patient Outcome(s): Required Intervention