MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 7-8 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71453177
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint reference number: (b)(4).
Event or Problem Description
It was reported that after a tka surgery was performed 8 years ago, the patient experienced post breakage (legion ps high flex xlpe size 7-8 10mm) after jumping down from a truck.This event was solved by performing a revision surgery on (b)(6) 2023, in which an identical post was placed in exchange.Patient's current health status is unknown.
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 the reported post breakage and subsequent revision reported were likely related to the patient jumping from a truck and is not associated with a mal performance of the implant.The current health status of the patient is unknown.Consequently, the patient impact beyond the revision and expected transient post-op convalescence period cannot be determined.Therefore, no further clinical assessment is warranted at this time.Should any additional relevant medical information be provided, this case would be re-assessed.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 in the warnings and precautions that the patient should be warned of surgical risks, and made aware of possible adverse effects.The patient should be warned that the device does not replace normal healthy bone, and that the implant can break or become damaged as a result of strenuous activity or trauma, and has a finite expected service life and may need to be replaced in the future.Additionally, fracture of the implant components has been identified in the possible adverse effects as a result of trauma, strenuous activity, improper alignment, or duration of service.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.According to the material specification, the quality and manufacture of the product material 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.Factors that could contribute to the reported event include patient anatomy, abnormal loading of limb, excessive forces 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.H11- corrected data.B2- outcomes attributed to adverse event.B5- describe event or problem.
Event or Problem Description
It was reported that after a tka surgery was performed in 2015, the patient experienced post breakage (legion ps high flex xlpe size 7-8 10mm) after jumping down from a truck.This event was solved by performing a revision surgery on (b)(6) 2023, in which an identical insert was placed in exchange.Patient's current health status is unknown.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 7-8 10MM
• 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: 16927090
• Report Number: 1020279-2023-01040
• Device Sequence Number: 6841378
• Product Code: JWH
• UDI-Device Identifier: 00885556487143
• UDI-Public: 00885556487143
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 06/05/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71453177
• Device Catalogue Number: 71453177
• 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: 04/17/2023
• Supplement Date Received by Manufacturer: 05/29/2023
• Initial Report FDA Received Date: 05/13/2023
• Supplement Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown
• Patient Weight: 110 KG