MAUDE Adverse Event Report: DEPUY CMW - 9610921 SMARTSET MV ENDURANCE 80G; BONE CEMENT : BONE CEMENT

Model Number 3102-080

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Pain (1994)

Event Date 08/23/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

Revision completed to address severe pain secondary to loosening of the tibial tray.Upon entering the joint, the tibial tray was loose at an unknown interface.The patella and femoral components were well-fixed and retained.There was no reported product problem with the revised tibial insert.The patient received an attune tibial revision construct.The procedure was completed without complications.Doi: (b)(6) 2018.Dor: (b)(6) 2021.Right knee.

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.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 MV ENDURANCE 80G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd.; blackpool IN FY4 4 QQ; UK FY4 4QQ
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14167757
• MDR Text Key: 289753214
• Report Number: 1818910-2022-07220
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 10603295168355
• UDI-Public: 10603295168355
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: 3102-080
• Device Catalogue Number: 3102080
• Device Lot Number: 8679579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ATTUNE FB TIB BASE SZ 6 CEM.; ATTUNE MEDIAL DOME PAT 38MM.; ATTUNE PS FB INSRT SZ 6 5MM.; ATTUNE PS FEM RT SZ 6 CEM.
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male