MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 5-6 13; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71421517
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/22/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tkr procedure was performed (b)(6) 2009, the patient had an accident and doctor believes he landed on the flexed knee, which fractured the ps post on the insert.A revision surgery was performed to treat the adverse event; on examination, the post appeared to have a reasonable amount of anterior wear.The patient outcome is unknown.
Additional Manufacturer Narrative
It was reported that, a revision surgery was performed for the poly insert in the patient's right side posterior stabilized legion tkr due to the ps post breakage.The patella was also revised due to the patella implant detaching from the cement while doing the soft tissue clean up around the patella.On examination, the post appears to have a reasonable amount of anterior wear.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 with the same failure mode.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.The cause of revision was stated as patient injury as the patient had an accident and doctor believes he landed on the flexed knee which fracture the post.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 5-6 13
• 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: 11155117
• Report Number: 1020279-2021-00278
• Device Sequence Number: 19866640
• Product Code: JWH
• UDI-Device Identifier: 03596010492951
• UDI-Public: 03596010492951
• 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: 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): 05/13/2021

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: 02/26/2019
• Device Model Number: 71421517
• Device Catalogue Number: 71421517
• Device Lot Number: 09BT28266
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 05/13/2021
• 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