MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II BICONVEX PAT 32MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71420572
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka that took place on (b)(6) 2008.A revision surgery had to be performed on (b)(6) 2023 due to the gns ii biconvex pat 32mm becoming dislodged, resulting in it freely moving in the knee.The current status of the patient is unknown.
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, as of the date of this medical investigation, the requested clinical documentation has not been provided.In the absence of the requested information, clinical factors which could have contributed to the reported event could not be definitively concluded.The patient impact beyond the reported patellar component dislodgement and subsequent revision could not be determined.No further medical assessment can be rendered at this time.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 for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed that improper fixation, and/or migration of the components could cause possible adverse effects.Also, the warnings and precautions section establishes that the implant can become damaged as a result of strenuous activity or trauma.The patient should be warned of surgical risks, and made aware of possible adverse effects.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.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include abnormal loading of limb, alignment, patient anatomy, procedural/user error and/or traumatic injury.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.

• Brand Name: GNS II BICONVEX PAT 32MM
• 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: 17687700
• Report Number: 1020279-2023-01729
• Device Sequence Number: 6378517
• Product Code: JWH
• UDI-Device Identifier: 03596010208286
• UDI-Public: 03596010208286
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2023

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 Expiration Date: 02/28/2018
• Device Catalogue Number: 71420572
• Device Lot Number: 08BM07149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 10/06/2023
• Date Device Manufactured: 02/28/2008
• 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: Required Intervention
• Patient Sex: Unknown