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

Model Number 5450-50-501

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); Discomfort (2330); Fibrosis (3167)

Event Date 01/21/2021

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

Patient received a right attune knee to treat osteoarthritis.The patella was resurfaced and depuy cement x 2 was utilized.There were no indicated intra-operative complications.Patient received a right knee revision to address pain, discomfort, and tibial tray loosening at the cement to implant interface.The surgeon noted the removal of fibrous tissue.All components were revised.The patient was revised with depuy components and cement x 4.There were no indicated intra-operative complications.Doi: (b)(6) 2014; 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: a device history record review was conducted as part of investigation in (b)(4).The record review and testing of retained samples did not reveal any non-conformances.

• Brand Name: SMARTSET GMV 40G US EO
• 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: 13156305
• MDR Text Key: 283243653
• Report Number: 1818910-2022-00131
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174295
• UDI-Public: 10603295174295
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K081163
• 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: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Model Number: 5450-50-501
• Device Catalogue Number: 545050501
• Device Lot Number: 7786711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2013
• 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 4 CEM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FB INSRT SZ 5 6MM; ATTUNE PS FEM RT SZ 5 NAR CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female