MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 7-8 11; PROSTHEIS,KNEE,PATELLOFEMOROTIB,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR

Model Number	71421523
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/11/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that when trying to implant the articular insert it didn't want to lock in place correctly.After numerous attempts a new insert needed to ordered and delivered from s&n.Delay greater than 30 minutes occured during surgery.
Additional Manufacturer Narrative
The associated genesis ii ps high flexion insert was returned and evaluated.A visual inspection of the product showed scratches and damage on the surface and the lock detail of the insert.The device was manufactured in 2009.A dimensional inspection was attempted; the damage/deformation at several features of the device would not allow for accurate measurement.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A clinical investigation noted that although surgery time was extended for this complaint, the procedure was completed successfully, and no patient harm or injury is being alleged.It was further reported that the patient outcome is to be as expected.No further clinical assessment is warranted.No further investigation warranted for this complaint; however we 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 PS HI FLEX ISRT SZ 7-8 11
• Common Device Name: PROSTHEIS,KNEE,PATELLOFEMOROTIB,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7726923
• Report Number: 1020279-2018-01347
• Device Sequence Number: 996493
• Product Code: JWH
• UDI-Device Identifier: 03596010492982
• UDI-Public: 03596010492982
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/06/2019
• Device Model Number: 71421523
• Device Catalogue Number: 71421523
• Device Lot Number: 09EM05880
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 07/11/2018
• Initial Report FDA Received Date: 07/27/2018
• Supplement Report FDA Received Date: 11/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other