MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 1-2 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71453204
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Arthralgia (2355); Swelling/ Edema (4577); Medical device site infection (4845)
Date of Event	10/17/2023
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 was performed on (b)(6) 2019, the patient experienced pain, swelling, fever and infection.A revision surgery was performed on the (b)(6) 2023 to treat this adverse event in which a lgn ps high flex xlpe sz 1-2 15mm was exchanged while a lgen ii 7.5mm resur pat 26mm, lgn rev tibia base sz 1 lt and a lgn ox constrained fem 3 lt remained.In addition, the surgeon does not believe that the product is at fault.The current health status of the patient remains unknown.
Additional Manufacturer Narrative
B2: outcomes attributed to adverse event.Section h3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per complaint details, a revision was performed almost 4 years post total knee arthroplasty due to the patient experienced pain, swelling, fever and infection.Reportedly, the surgeon does not believe that the product is at fault.It was communicated that the requested medical documentation was not available; therefore, clinical factors (and/or source of the infection) which could have contributed to the reported event could not be definitively concluded and a causal relationship could not be confirmed.The patient impact beyond the reported unspecified symptomatic infection and insert revision could not be determined.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed that infection has been identified in possible adverse effects.Active, local infection or previous intra-articular infections are identified in contraindications for total knee replacement.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.Additionally, since the device batch number was not provided, a review of the sterilization records could not be performed.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 injury, patient condition and/or medical history.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: LGN PS HIGH FLEX XLPE SZ 1-2 15MM
• 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: 18100847
• Report Number: 1020279-2023-02185
• Device Sequence Number: 12692280
• Product Code: JWH
• UDI-Device Identifier: 00885556034989
• UDI-Public: 00885556034989
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2023

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 Catalogue Number: 71453204
• Device Lot Number: UNKNOWN
• 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: 10/17/2023
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: 71421163 / LOT: UNKNOWN.; PN: 71424001 / LOT: UNKNOWN.; PN: 71932634 / LOT: UNKNOWN.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown