MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 3-4 13; PROSTHESISKNEEPATELLOFEMOROTIBIALSEMICONSTRAINEDCEMENTEDPOLYMERMETALPOLYMER

Catalog Number	71421510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, insert couldn't be implanted.A backup device from smith and nephew was used to complete the procedure.There was a delay greater than 30 minutes but no patient impact.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device has signs of damage from the attempted insertion.The device was manufactured in 2019.A dimensional inspection was attempted but the device was too damaged from the attempted insertion to obtain accurate measurements.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: GII PS HI FLEX ISRT SZ 3-4 13
• Common Device Name: PROSTHESISKNEEPATELLOFEMOROTIBIALSEMICONSTRAINEDCEMENTEDPOLYMERMETALPOLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9400890
• Report Number: 1020279-2019-04254
• Device Sequence Number: 2626389
• Product Code: JWH
• UDI-Device Identifier: 03596010492920
• UDI-Public: 03596010492920
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2019

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 Catalogue Number: 71421510
• Device Lot Number: 19CM17476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 12/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1