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
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/23/2018
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: PRSTHSIS,KNEE,PATLLOFMOROTIBIAL,SMI-CNSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7908172
• Report Number: 1020279-2018-01866
• Device Sequence Number: 16564825
• Product Code: JWH
• UDI-Device Identifier: 03596010206305
• UDI-Public: 03596010206305
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/04/2018
• Device Catalogue Number: 71420174
• Device Lot Number: 18DM09530
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 11/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1