MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II CEMENTED TIBIAL B/PLATE SZ 8 LEFT; PRSTHSIS,KNEE,PATLLOFMOROTIBIAL,SMI-CNSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 71420174

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Information (3190)

Event Date 08/23/2018

Event Type  Injury  

Event Description

It was reported that during the tkr procedure the first layer of the sterile packaging has a chip out of the side.There was no sign of the chip in the packaging.The surgeon carefully examined the second layer of sterile packaging and found it to be intact.He proceeded to use the item.No serious injury or medical intervention reported.

Manufacturer Narrative

The packaging for the gii cemented tibial plate was returned and evaluated.A visual inspection found that the flange corner of the first sterile plastic container has broken off; it was not returned.An evaluation of the packaging found that the damage more than likely occurred during transit.No additional complaints have been found for the associated lot number.Reviewing the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Based on this investigation, the need for corrective action is not indicated.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GEN II CEMENTED TIBIAL B/PLATE SZ 8 LEFT
• Type of Device: PRSTHSIS,KNEE,PATLLOFMOROTIBIAL,SMI-CNSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7908172
• MDR Text Key: 121699860
• Report Number: 1020279-2018-01866
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010206305
• UDI-Public: 03596010206305
• Combination Product (y/n): N
• PMA/PMN Number: K951987
• 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: 11/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2018
• Device Catalogue Number: 71420174
• Device Lot Number: 18DM09530
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1