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 Pain (1994)

Event Date 08/16/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.Dmf# - 13704.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

Medical records received ad 26 mar 2021 on (b)(6) 2021, the patient underwent a left knee revision to address pain and tibial tray loosening at an unknown interface.The tibial insert, tibial tray, and femoral component were revised.The patella component was retained.The patient was revised with competitor products.There were no indicated intra-operative complications.Doi: unknown, dor: (b)(6) 2021, left knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.All available photographs were reviewed, and the loosening allegation can be confirmed.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot a previous device history record review was conducted as part of investigation (b)(4).The record review did not reveal any related manufacturing deviations or anomalies.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 FY4 4 QQ; UK FY4 4QQ
• 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: 12617154
• MDR Text Key: 276096250
• Report Number: 1818910-2021-22621
• 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,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: 5450-50-501
• Device Catalogue Number: 545050501
• Device Lot Number: 8178371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2015
• 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 7 CEM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS FB INSRT SZ 7 12MM; ATTUNE PS FEM LT SZ 7 CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male