MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SMARTSET HV BONE CEMENT 40G; BONE CEMENT : BONE CEMENT

Model Number 3092-040

Device Problem Off-Label Use (1494)

Patient Problem Insufficient Information (4580)

Event Date 07/14/2014

Event Type  Injury  

Event Description

Dor: (b)(6) 2021.Patient received a left knee revision to treat pain, swelling, stiffness, and instability secondary to loosening of the tibial tray.Upon entering the joint, the surgeon identified and debrided scar tissue.The tibial tray was loose at an unknown interface and revised.The femoral component was revised to accommodate the revision construct.The patella was retained.There was no reported product problem with the revised tibial insert.The patient received a competitor revision construct secured with competitor cement.The procedure was completed without complications.Mua: (b)(6) 2021.Patient received a manipulation under anesthesia for unknown reasons.No further information available.Doi: (b)(6) 2018, doe: (b)(6) 2018 (mua), dor: (b)(6) 2021, ((b)(4) revision to competitor construct with retained patella), doe: (b)(6) 2021 (mua).

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: (b)(6).The device indicated in section d of the med watch was also reported on (b)(4) as the patient experienced adverse events on different days with the same device.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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 HV BONE CEMENT 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13826164
• MDR Text Key: 287588015
• Report Number: 1818910-2022-04963
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 10603295168331
• UDI-Public: 10603295168331
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033563
• 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: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 3092-040
• Device Catalogue Number: 3092040
• Device Lot Number: 8651773
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2017
• 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: AGMNT FIB KNEE (STRYKER) LOT # GU37U.; ATTUNE MEDIAL DOME PAT 38MM.; BASEPLATE TIBIAL (STRYKER) LOT # GLH4DA.; BONE CEMENT (STRYKER).; BONE CEMENT (STYKER) LOT # MLBO61.; FEMORAL KNEE (STRYKER)LOT # GHB4A.; STEM EXTENSION (STRYKER) LOT # 0108433A.; STEM EXTENSION KNEE (STRYKER) LOT # 0108442A.; TIBIAL AUGMENT (STRYKER) LOT # P2071.; TIBIAL INSERT (STRYKER) LOT # T11REH.
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female