MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 5-6 11; PRSTHSS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CNSTRND,CEMENTED,POLY/METAL/POLY

Model Number	71421516
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery it was noticed that the doctor couldn't get the insert to sit securely into the tibial base plate.A second insert of the same size and thickness was opened and went in with no problem.There was a delay less than or equal to 30 minutes.No injury reported.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing or product specifications did not reveal abnormalities that could have contributed to the reported issue.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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.We consider this investigation closed.

• Brand Name: GII PS HI FLEX ISRT SZ 5-6 11
• Common Device Name: PRSTHSS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CNSTRND,CEMENTED,POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10872099
• Report Number: 1020279-2020-06586
• Device Sequence Number: 11713087
• Product Code: JWH
• UDI-Device Identifier: 03596010492333
• UDI-Public: 03596010492333
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 06/07/2021

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: 07/23/2024
• Device Model Number: 71421516
• Device Catalogue Number: 71421516
• Device Lot Number: 14GT44497
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 06/05/2021
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1