MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN GENESIS II TOTAL KNEE TIB INSERT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNKN01200120

Device Problem Break (1069)

Patient Problems Fall (1848); Failure of Implant (1924); Joint Laxity (4526)

Event Date 06/11/2021

Event Type  Injury  

Event Description

It was reported that, after a tka, a genesis ii insert snapped off.A revision surgery was performed on an unknown date to treat this adverse event.A hi flex tibial insert was changed.The patient was not injured beyond the described event.No other complications were reported.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, the patient required an insert revision due to instability ¿after a fall¿.Reportedly, the hf poly tibial insert was found to have the post snapped off; therefore, it was replaced with a new poly.Responses to the requested clinical documentation had not been received as of the date of this medical investigation.Without the requested medical documentation, the root cause of the reported event could not be fully assessed; however, it was reported that the instability occurred ¿after a fall¿.The patient impact beyond the reported fall, subsequent instability, and revision with findings of a fractured post could not be determined.No further medical assessment could be rendered at this time.Should additional clinically relevant documentation become available the medical investigation task may be re-evaluated.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but are not limited to traumatic injury, abnormal loading of limb or excessive forces applied to implant.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

Manufacturer Narrative

H3, h6: the device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device's post component was broken off.The post was returned with the rest of the device.The clinical/medical evaluation concluded that per complaint details, the patient required an insert revision due to instability ¿after a fall¿.Reportedly, the hf poly tibial insert was found to have the post snapped off; therefore, it was replaced with a new poly.Responses to the requested clinical documentation had not been received as of the date of this medical investigation.Without the requested medical documentation, the root cause of the reported event could not be fully assessed; however, it was reported that the instability occurred ¿after a fall¿.The patient impact beyond the reported fall, subsequent instability, and revision with findings of a fractured post could not be determined.No further medical assessment could be rendered at this time.Should additional clinically relevant documentation become available the medical investigation task may be re-evaluated.The contribution of the device to the reported event could be corroborated.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.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.

• Brand Name: UNKN GENESIS II TOTAL KNEE TIB INSERT
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 12063780
• MDR Text Key: 258358011
• Report Number: 1020279-2021-05443
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01200120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention