MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK CEMENT DELIVERY DEVICE

Catalog Number UNK CEMENT DELIVERY DEVICE

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2020

Event Type  malfunction  

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.

Event Description

The primary surgery was performed on (b)(6) 2020 via tka with another company¿s implants.During the surgery, when the surgeon used the cement, he could not use it because the base of the cement¿s tube had broken.The surgery was completed with backup device.It was unknown whether there was any surgical delay.No further information is available.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary
=
> no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Component code appropriate term/code not available (g07002) is used to capture product not returned.

• Brand Name: UNK CEMENT DELIVERY DEVICE
• Type of Device: CEMENT DELIVERY DEVICE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10546639
• MDR Text Key: 208153631
• Report Number: 1818910-2020-20321
• Device Sequence Number: 1
• Product Code: KIH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK CEMENT DELIVERY DEVICE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 09/17/2020
• Supplement Dates Manufacturer Received: 11/30/2020
• Supplement Dates FDA Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VMP ENDURANCE 80G