MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 3-4 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71453211
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arthralgia (2355); Joint Laxity (4526)
Date of Event	05/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after tka surgery performed on (b)(6) 2017, the patient experienced instability and pain in knee.Surgeon stated to believe that the pain was mainly due to the patient´s cerebral palsy diagnosis.This adverse event was treated via revision surgery on (b)(6) 2023, in which the lgn ps high flex xlpe sz 3-4 9mm was replaced to help with stability and the gii oval resurfacing pat 29mm was replaced to help with the patellofemoral joint pain.The patient left surgery in good health.Patient's current health status is unknown.No further information available at this moment.
Additional Manufacturer Narrative
H3, h6: the devices were 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 approximately 5.5 years post implantation due to instability and pain in the knee which was reported as ¿mainly due to the patient¿s cerebral palsy diagnosis¿.It was reported that the revision consisted of an insert replacement with a constrained poly to help with stability along with replacement of the resurfacing patella component to help with the patellofemoral joint pain.The patient left the surgery in good health per reported complaint; however, the current patient status is unknown.It was communicated that the requested clinical documentation was not available.Based on the information provided, the reported patient diagnosis could not be ruled out as a contributing factor to the reported event.Patient impact beyond the reported instability and patellofemoral joint pain cannot be determined.No further medical assessment can be rendered at this time.Device batch numbers were not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history of the previous 12 months revealed similar events for the listed devices, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for knee systems revealed in the possible adverse effects section that excessive rotation, decreased range of motion, lengthening or shortening of the leg, looseness of components, unusual stress concentrations, and extraneous bone can 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.Additionally, temporary or permanent nerve damage can result in pain or numbness of the affected limb.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.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Additional factors that could contribute to the reported event include joint laxity, traumatic injury, joint tightness, patient condition or postoperative care.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.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 3-4 9MM
• 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: 17089558
• Report Number: 1020279-2023-01251
• Device Sequence Number: 6088679
• Product Code: JWH
• UDI-Device Identifier: 00885556035252
• UDI-Public: 00885556035252
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2023

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 Model Number: 71453211
• Device Catalogue Number: 71453211
• 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: 05/22/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 07/25/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 71421029 // GII OVAL RESURFACING PAT 29MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female