MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII P/S ALL POLY TB SZ4 13MM LT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71420380
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tibia implant could not be reduced at the time of implanting.Delay longer than 30 minutes was reported.Device backup available.
Additional Manufacturer Narrative
The affected genesis ii p/s all poly tibial base along with its packaging was returned and evaluated.Our investigation including a visual inspection of the product showed no obvious signs of damage.A dimensional inspection was performed which noted all features measured within specification.The device was manufactured in 2016.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.There is no information that would suggest the device failed to meet specifications.A clinical evaluation noted that the extended surgery time did not result in any patient harm therefore further clinical assessment is warranted and no future harm to patient is anticipated.No further investigation warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GII P/S ALL POLY TB SZ4 13MM LT
• 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: 8582613
• Report Number: 1020279-2019-01766
• Device Sequence Number: 3236145
• Product Code: JWH
• UDI-Device Identifier: 03596010207333
• UDI-Public: 03596010207333
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K953274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2019

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 Expiration Date: 01/08/2026
• Device Catalogue Number: 71420380
• Device Lot Number: 16AM05716
• Initial Date Received by Manufacturer: 04/12/2019
• Supplement Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 09/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1