MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 3-4 15; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAIND, CEMENTD, POLY/METAL/POLY

Model Number	71421511
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	10/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent revision surgery due to medial laxity/gapping.During the revision surgery the surgeon swapped the 15 mm hifelx insert for a 21 mm.
Additional Manufacturer Narrative
It was reported that the patient underwent revision surgery due to medial laxity/gapping.The surgeon swapped the 15 mm hi-flex insert for a 21 mm.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device details were not made available, device history record review cannot be completed.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode.The lot is unknown for this part.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.No medical documents were received for investigation, therefore, no medical assessment can be performed at this time.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.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 15
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAIND, CEMENTD, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10797203
• Report Number: 1020279-2020-06262
• Device Sequence Number: 19747127
• Product Code: JWH
• UDI-Device Identifier: 03596010492937
• UDI-Public: 03596010492937
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2021

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 Model Number: 71421511
• Device Catalogue Number: 71421511
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 02/08/2021
• 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: Hospitalization; Required Intervention