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

Catalog Number	71421509
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
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 was performed on an unknown date, during which a genesis ii baseplate, a legion ps femur, and a ps-hi-flex insert were placed, the patient experienced poly dissociation.The surgeon stated that the locking mechanism of the genesis ii baseplate is very robust; however, he ensured during the surgery that the poly was properly locked in.It is unknown how this adverse event was treated.The patient's current health status is unknown.
Event or Problem Description
It was reported that, after a tka was performed in dec-2021, during which a gns ii cmt tib size 4 {} right, a legion ps femur, and a gii ps hi flex isrt sz 3-4 11 were placed, the patient experienced poly dissociation.The surgeon stated that the locking mechanism of the genesis ii baseplate is very robust; however, he ensured during the surgery that the poly was properly locked in.It is unknown how this adverse event was treated.The patient's current health status is unknown.
Additional Manufacturer Narrative
Additional information: d10 corrected data: b5.
Event or Problem Description
It was reported that, after a tka was performed on (b)(6) 2021, during which a genesis ii baseplate, a legion ps femur, and a gii ps hi flex isrt sz 3-4 11 were placed, the patient experienced poly dissociation.The surgeon stated that the locking mechanism of the genesis ii baseplate is very robust; however, he ensured during the surgery that the poly was properly locked in.It is unknown how this adverse event was treated.The patient's current health status is unknown.
Additional Manufacturer Narrative
H3,h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.For the insert and tibial baseplate, a review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the device did not reveal similar events for the listed devices.A review of the risk management files 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 these products and event.The specific identifiers for the femoral component were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, risk management files and prior actions could not be performed.A review of the instructions for use documents for knee systems revealed in warnings and precautions that repeated assembly and disassembly of the modular components could compromise a critical locking action of the components.Surgical debris must be cleaned from components before assembly.Debris inhibits the proper fit and locking of modular components which may lead to early failure of the procedure.Modular components must be assembled securely to prevent disassociation.Additionally, a review was performed to determine if there was an increased trend for ps-hi-flex inserts dissociation.Only 12 complaints that involved disassociation were found for all ps-hi-flex insert catalog items in the past 24 months.It was concluded that no trends were found in the data in terms of customer or even by part number.Additionally, a review of the drawing history for both versions of these ps hf inserts revealed that no design changes have been made in the last 5 years.Moreover, there have been no production changes in the past 24 months.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, patient condition, postoperative care, size selected or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Should the devices 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.H6: health effect - impact code.

• 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: 19741649
• Report Number: 1020279-2024-01375
• Device Sequence Number: 7775959
• Product Code: JWH
• UDI-Device Identifier: 03596010492364
• UDI-Public: 3596010492364
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/25/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71421509
• Device Lot Number: 21DM05277
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2024
• Supplement Date Received by Manufacturer: 09/26/2024; 10/03/2024; 10/18/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 09/30/2024; 10/08/2024; 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GNS II CMT TIB SIZE 4 {} RIGHT//71420184//21GM0244.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown