MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS INSERT SZ 1-2 18MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71420810
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Joint Dislocation (2374); Joint effusion (4849)
Date of Event	01/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
It was reported that, after a tka surgery was performed on (b)(6) 2023, the patient experienced a trauma in the left knee at standstill, twisted inwards with subsequent pain afterwards and sensation of instability, worsening of effusion.Additional, hyperalgesia despite immobilization with splint, control radiographs showed dislocation of the polyethylene insert.This adverse event was treated by a revision surgery on (b)(6) 2024, in which a gii ps insert sz 1-2 18mm was exchanged.Patient's current health status is recovering.
Additional Manufacturer Narrative
Section h6 was updated.Section h10: the associated device was returned and evaluated.The visual inspection revealed multiple gouges and scratches throughout the device.The device show signs of wear.This inspection was conducted by naked eye.A dimensional evaluation could not be performed due to damage/deformation from use of the explanted device.There is no evidence to indicate that the product was defective at the time of shipment from the manufacturing site.This device is subjected to multiple visual and dimensional inspection during processing, and this type of damage has a high likelihood of detection during these inspections.Dimensional inspection states that the damage to the device would not allow for accurate measurement.The clinical/medical investigation concluded that, based on the information provided, the trauma experienced by the patient was the likely cause of the poly dislocation, but it is unknown the root cause.The patient impact beyond the reported trauma, pain, instability, worsening effusion, the poly dislocation, and the subsequent revision could not be determined since the patient is still recovering.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 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 dislocation has been identified in possible adverse effects section as a result from trauma, improper implant selection, improper implant positioning, improper fixation, and/or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions.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 evidence to conclude that the product 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 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 for future complaints and investigate as necessary.Internal complaint reference number: (b)(4).

• Brand Name: GII PS INSERT SZ 1-2 18MM
• 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: 18913060
• Report Number: 1020279-2024-00533
• Device Sequence Number: 12469131
• Product Code: JWH
• UDI-Device Identifier: 03596010209542
• UDI-Public: 03596010209542
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2024

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: 71420810
• Device Lot Number: G2200852
• 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: 02/19/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2022
• 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
• Patient Age: 37 YR
• Patient Sex: Female