MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 7-8 9; PRSTHSS,KN,PTLLFMRTBL,SM-CNSTRND,CMNTD,PLYMR/MTL

Catalog Number	71421522
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	05/12/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery of tka was performed due to fracture at the post of the genesis ii size 7-8 9mm ps hiflex insert.The cause of the implant fracture is unknown and so is the patient outcome.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.The post fractured off the device and was returned.The device was manufactured in 2009 and shows signs of extensive wear.The knee insert post deformation and/or fracture may have been due to repeated posterior contact of the femoral cam on the post combined with excessive posterior to anterior shear force during activity.However, this could not be isolated as the root cause for this particular failure mode.A lab analysis was conducted and the component was inspected visually to determine the cause of the reported incident.No destructive analysis was conducted during this investigation.The articulating and non-articulating surfaces of the insert are worn with some discoloration.Damage is present on the edge of the articulating surface.The post is fractured near the base.There were no observations of material or manufacturing deviations in the course of this investigation.A medical investigation was conducted and confirms this complaint from australia reports the revision of a genesis ii knee secondary to the post breaking.¿the cause of the implant fracture is unknown and so is the patient outcome.¿ it has been communicated that no medical documentation will be forthcoming.Smith and nephew has not received adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.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.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Some potential probable causes for this event could include but not limited to traumatic injury, surgical technique, implant failure or design of device.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; 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 7-8 9
• Common Device Name: PRSTHSS,KN,PTLLFMRTBL,SM-CNSTRND,CMNTD,PLYMR/MTL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10127275
• Report Number: 1020279-2020-02143
• Device Sequence Number: 3816669
• Product Code: JWH
• UDI-Device Identifier: 03596010492975
• UDI-Public: 3596010492975
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

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 Catalogue Number: 71421522
• Device Lot Number: 09CT30079
• Initial Date Received by Manufacturer: 05/12/2020
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 06/08/2020
• Supplement Report FDA Received Date: 06/16/2021
• 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