MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS INSERT SZ 3-4 9MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71420816
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgical procedure, when final tibial insert was placed with size 3-4 of 9 mm (height), it was evident that it did not fit perfectly, leaving a light of space between the tibial plate and the insert.Several attempts were made with the corresponding positioner, but it was not possible to get a perfect placement, it was necessary to hit it with the hammer.Procedure delayed no longer than 30 minutes.No backup was required.
Additional Manufacturer Narrative
The associated complaint device was not returned.A review of the provided pictures confirmed the stated failure mode.The device did not seat properly during the attempted insertion.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.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, the complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: GII PS INSERT SZ 3-4 9MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8738219
• Report Number: 1020279-2019-02469
• Device Sequence Number: 1489988
• Product Code: JWH
• UDI-Device Identifier: 03596010209573
• UDI-Public: 03596010209573
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2019

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: 71420816
• Device Lot Number: J1900961
• Initial Date Received by Manufacturer: 06/05/2019
• Supplement Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1