MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 3-4 11; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71421509
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka surgery had been performed on (b)(6) 2009, the post of a gii ps hi flex isrt sz 3-4 11 implant fractured.A revision surgery was performed on (b)(6) 2021 in order to exchange the implant.Current health status of patient is unknown.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The contribution of the device to the reported event could not be corroborated.The tibial insert showed damage to the articulating surface as well as the inferior surface of the insert.The anterior insertion divot is damaged in line with what may be expected by removal of the implant.The inferior surface is damaged which may have been a result of movement of the implant in vivo or caused during extraction.The locking details are intact.The post is separated from the main body of the implant, with damage along the cam interface, as well as along the anterior side of the post.No material or manufacturing defects were observed in the course of this investigation.A review of complaint history revealed similar events for the listed device, but no similar events for the batch, this failure mode will be monitored for future complaints for any necessary corrective actions.The clinical/medical evaluation concluded that per the compliant details, no relevant clinical information will be provided for inclusion in this medical investigation.Without the requested clinical information, a thorough medical investigation cannot be rendered, nor can the root cause of the reported implant fracture be determined.Based on the information provided, a revision was performed to exchange the explant.However, the impact to the patient beyond that which has already been reported is unknown.Should any additional relevant clinical documentation be provided, this complaint would be re-assessed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.
Additional Manufacturer Narrative
The associated device was returned and evaluated.The visual inspection on the lab analysis concluded that the tibial insert showed damage to the articulating surface as well as the inferior surface of the insert.The anterior insertion divot is damaged in line with what may be expected by removal of the implant.The inferior surface is damaged which may have been a result of movement of the implant in vivo or caused during extraction.The locking details are intact.The post is separated from the main body of the implant, with damage along the cam interface, as well as along the anterior side of the post.No material or manufacturing defects were observed in the course of this investigation.A review of complaint history revealed similar events for the listed device, but no similar events for the batch, this failure mode will be monitored for future complaints for any necessary corrective actions.The clinical/medical evaluation concluded that per the compliant details, no relevant clinical information will be provided for inclusion in this medical investigation.Without the requested clinical information, a thorough medical investigation cannot be rendered, nor can the root cause of the reported implant fracture be determined.Based on the information provided, a revision was performed to exchange the explant.However, the impact to the patient beyond that which has already been reported is unknown.Should any additional relevant clinical documentation be provided, this complaint would be re-assessed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GII PS HI FLEX ISRT SZ 3-4 11
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12087890
• Report Number: 1020279-2021-05547
• Device Sequence Number: 19664316
• Product Code: JWH
• UDI-Device Identifier: 03596010492364
• UDI-Public: 03596010492364
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2022

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: 05/17/2019
• Device Model Number: 71421509
• Device Catalogue Number: 71421509
• Device Lot Number: 09EM12916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 01/10/2022; 03/25/2022
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 01/11/2022; 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 86 KG