MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 3-4 9; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71421508
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	09/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, after a tka surgery performed on (b)(6) 2011, the patient was complaining of an unstable knee and a/p instability was noted.On (b)(6) 2021 a revision surgery was performed and it was found that the genesis ii posterior stabilized high flexion insert size 3-4 9 mm (-1) was disengaged from the locking mechanism on the unknown genesis ii total knee tibial baseplate (-2).Both devices presented severe wear on the posterior aspect.Current health state of the patient is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the disengaging and wear was confirmed.The clinical/medical investigation concluded that, based on the information provided the reported insert disengagement from the locking mechanism along with the noted radiolucency at the tibial stem cement mantle/bone interface were most likely contributing factors.Trauma could not be ruled out as a potential contributing factor.The patient impact was the reported instability, component disassociation/wear/loosening and revision.Further patient impact could not be determined.No further clinical/medical assessment can be rendered at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no 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 fit/sizing issue, lifetime of device, patient condition, friction or joint tightness.Based on this investigation, the need for corrective action is not indicated.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.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The manufacturing process of the device did not contribute to the reported event.A visual inspection of the returned device confirmed the stated failure mode.The device shows signs of severe natural wear especially along the base and post of the device.There is also some discoloration likely from exposure to bodily fluids over time.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 based on the information provided the reported insert disengagement from the locking mechanism along with the noted radiolucency at the tibial stem cement mantle/bone interface were most likely contributing factors.Trauma could not be ruled out as a potential contributing factor.The patient impact was the reported instability, component disassociation/wear/loosening and revision.Further patient impact could not be determined.No further clinical/medical assessment can be rendered at this time.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.

• Brand Name: GII PS HI FLEX ISRT SZ 3-4 9
• 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: 12529674
• Report Number: 1020279-2021-07141
• Device Sequence Number: 983328
• Product Code: JWH
• UDI-Device Identifier: 03596010492357
• UDI-Public: 03596010492357
• 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: 2011
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2022

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: 03/02/2021
• Device Model Number: 71421508
• Device Catalogue Number: 71421508
• Device Lot Number: 11CT04372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 10/22/2021; 01/26/2022
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 10/26/2021; 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2011
• 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; Other
• Patient Age: 65 YR
• Patient Sex: Female