MAUDE Adverse Event Report: DEPUY CMW - 9610921 UNK CEMENT SMARTSET GMV; BONE CEMENT

Catalog Number UNK CEMENT SMARTSET GMV

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Insufficient Information (4580)

Event Date 04/03/2023

Event Type  Injury  

Event Description

It was reported that the patient's knee was revised due to aseptic tibial loosening and subsidence at cement to implant interface.The patient's primary attune fixed bearing tibial base and cruciate retaining fixed bearing insert were removed and replaced by attune revision components.There was no cement attached to the underside of the tibial base, which would suggest that there was a flaw in the design of the tibial base according to the surgeon depuy smartset gmv bone cement was use during the primary procedure.The lot numbers for the cement used is not available, since it was ordered directly from depuy by the hospital.Doi: (b)(6) 2017.Dor: (b)(6) 2023.Affected side : left knee.

Manufacturer Narrative

Product complaint # (b)(4).D4-the device catalog number is unknown; therefore, udi is unavailable.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.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Dmf# - 13704.Trade name gentamicin sulphate.Active ingredient(s) gentamicin sulphate.Dosage form - powder.Strength 1.0g active in our cements.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNK CEMENT SMARTSET GMV
• Type of Device: BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16770879
• MDR Text Key: 313597107
• Report Number: 1818910-2023-08228
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK CEMENT SMARTSET GMV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 CR FB INSRT SZ 4 6MM; ATTUNE FB TIB BASE SZ 3 CEM; UNK CEMENT SMARTSET GMV
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female