MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 7-8 9; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71421522
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka had been performed, the patient experienced a fall and the post of the insert broke.A revision surgery was performed to exchange the insert.The patient outcome is unknown.No additional information provided at this time.
Additional Manufacturer Narrative
H3, h6: it was reported that a revision surgery was performed and the poly was exchanged due to post breakage after the patient fall.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes that could have caused or contributed to the reported incident.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 the complaint history for the listed part revealed no prior complaints for the listed batch.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.A clinical analysis noted that no relevant supporting clinical information has been provided to assist with a clinical investigation.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.The cause of revision was stated as patient injury.Based on this investigation, the need for corrective action is not indicated.No further investigation is 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 PS HI FLEX ISRT SZ 7-8 9
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11168559
• Report Number: 1020279-2021-00378
• Device Sequence Number: 16943524
• Product Code: JWH
• UDI-Device Identifier: 03596010492975
• UDI-Public: 03596010492975
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/29/2018
• Device Model Number: 71421522
• Device Catalogue Number: 71421522
• Device Lot Number: 08MT26767
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 05/19/2021
• 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