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

Catalog Number 3172080

Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Chemical Problem (2893)

Patient Problem Insufficient Information (4580)

Event Date 02/22/2022

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2022, the patient underwent the tka surgery for oa with the cements in question.In the surgery, the surgeon felt that mixing was strange, and many lumps were found in the prepared cement.This cement was discarded.The surgeon felt strange with the newly used cement too, but as there was no spare, she used it as it was.The surgery was completed successfully within 30 minutes delay.In this hospital, the same surgeon performs the mixing task every time.She mixed it with the same procedure as usual, but she felt strange with the cement that was made.The surgeon commented to investigate whether there was any problem with other manufactured products in the same lot.No further information is available.

Manufacturer Narrative

Product complaint # (b)(4).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)(6).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.

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 manufacturing record evaluation (nc search) was performed for the finished device product code - 3172080, lot number - 9905844, and no non-conformances / manufacturing irregularities were identified.

• Brand Name: VMP 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13769209
• MDR Text Key: 288677450
• Report Number: 1818910-2022-04653
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup,Followup,Followup,Followup
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3172080
• Device Lot Number: 9905844
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• 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: VMP ENDURANCE 80G