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

Catalog Number 3095040

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

Patient Problem Pain (1994)

Event Date 08/30/2021

Event Type  Injury  

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.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 primary attune ps rp tkr in 2019 - patella was not resurfaced at time of primary surgery.Patient has been developing anterior knee pain over the last few months, mr (b)(6) has reviewed the patient and opted to resurface the patella.Doi: 2019, dor: (b)(6) 2021, unknown side.

• 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: 12750957
• MDR Text Key: 280086911
• Report Number: 1818910-2021-24374
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 10/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3095040
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ATTUNE PS FEM LT SZ 6 CEM; ATTUNE PS RP INSRT SZ 6 8MM; ATTUNE RP TIB BASE SZ 6 CEM; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G
• Patient Outcome(s): Required Intervention