MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS INSERT SZ 5-6 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71420832
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	11/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka surgery was performed on (b)(6) 2010, the post that was implanted broke on the tibial insert.The patient only experienced an unstable knee.The was no traumatic event reported.This adverse event was treated by a revision surgery on (b)(6) 2023, in which a gii ps insert sz 5-6 11mm was exchanged.Patient's current health status is recovered since the poly exchange procedure.
Additional Manufacturer Narrative
H10: internal complaint reference: case-(b)(4).
Additional Manufacturer Narrative
H10: h3, h6: the associated device was returned and evaluated.The visual inspection revealed that the post fractured off the implant.This piece was returned.The implant reveals discoloration and signs of 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.Some additional factors that could have contributed to the reported event include patient anatomy, abnormal loading of limb and/or traumatic injury.The clinical/medical investigation stated that the request clinical documentation was not provided for review.Therefore, there were no clinical factors identified which would have contributed to the reported broken post.The patient impact includes the unstable knee, revision surgery, and associated recovery period symptoms.Reportedly, the patient¿s current health status is recovered.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 12 months, however no commonalities that would suggest a device deficiency were found nor an adverse trend.In addition, no similar events for the batch were found based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for knee systems revealed that the implant can break or become damaged as a result of strenuous activity or trauma.This has been identified as a warning and precaution.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.Verifying that parts are free of burrs, pits, sharp edges, nicks or damaged areas shall be performed within the steps of the receiving inspection.Besides, per material specification, the quality and manufacture of polyethylene as ram-extruded rod and compression-molded rod and plate shall be controlled.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.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 for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GII PS INSERT SZ 5-6 11MM
• 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: 18302479
• Report Number: 1020279-2023-02465
• Device Sequence Number: 6983933
• Product Code: JWH
• UDI-Device Identifier: 03596010209658
• UDI-Public: 03596010209658
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2024

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: 06/02/2019
• Device Catalogue Number: 71420832
• Device Lot Number: 09FM03877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male