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 Problem Local Reaction (2035)

Event Date 10/28/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Initial reporter occupation: lawyer.Dmf# - (b)(4), 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 medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Records indicate the patient received a right attune total knee arthroplasty.No allegations provided of patient injury or product failure, nor report of revision.Doi: (b)(6) 2017, dor: unknown (right).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : medical records reviewed.This event has been determined to be an npi as there is no allegation of deficiency related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a depuy device after it was released for distribution.There is no adverse event involving a depuy device.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• 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: 10980042
• MDR Text Key: 220645756
• Report Number: 1818910-2020-26635
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174295
• UDI-Public: 10603295174295
• Combination Product (y/n): Y
• PMA/PMN Number: K081163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: 5450-50-501
• Device Catalogue Number: 545050501
• Device Lot Number: 8378515
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE FB TIB BASE SZ 3 CEM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FB INSRT SZ 4 12MM; ATTUNE PS FEM RT SZ 4 NAR CEM; SMARTSET GMV 40G US EO
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR