MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN XLPE DISHED ISRT SZ 1-2 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71453272
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Damage to Ligament(s) (1952); Joint Dislocation (2374)
Date of Event	12/26/2022
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 had been performed on (b)(6) 2022 to address osteoarthritis symptoms, the patient experienced a prosthetic tibiofemoral posterior dislocation.The adverse event has been treated with physical therapy.The clinical outcome of the patient was reported as "ongoing".
Additional Manufacturer Narrative
B5: describe event or problem, h6: health effect - clinical code and health effect - impact code.Section h3, h6: given the nature of the alleged incident, the devices, could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, the electronic clinical report form documented that ¿clinically knee appears posteriorly dislocated with disruption of the posterior cruciate ligament¿ and documented the serious adverse event as moderate severity unrelated to the study device with patient discharge.Based on the information provided, the patient fall at approximately 5 weeks post-implantation was the precipitating factor to the prosthetic tibiofemoral posterior dislocation.There was no supporting evidence of a component malperformance.The patient impact beyond the reported fall with subsequent dislocation with posterior cruciate ligament disruption, hospitalization, and prescribed brace with physical therapy could not be determined.No further medical assessment can be rendered at this time.A review of the production orders for the listed devices 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 instructions for use documents for knee systems revealed in the possible adverse effects that dislocation and subluxation can result from trauma.Muscle and fibrous tissue laxity can also contribute to these conditions.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 this 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.According to the clinical/medical conclusions, the root cause of this event was determined to be the patient fall.Based on this investigation, the need for corrective action is not indicated.Should any 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: medical device problem code.
Event or Problem Description
It was reported that, after a tka surgery had been performed on (b)(6) 2022 to address osteoarthritis symptoms, the patient experienced a prosthetic tibiofemoral posterior dislocation after a fall.The adverse event has been treated with rom brace locked at 10 degree flexion and physical therapy.The clinical outcome of the patient was reported as "ongoing".

• Brand Name: LGN XLPE DISHED ISRT SZ 1-2 11MM
• 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: 16439933
• Report Number: 1020279-2023-00412
• Device Sequence Number: 3199026
• Product Code: JWH
• UDI-Device Identifier: 00885556255742
• UDI-Public: 00885556255742
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2023

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: 71453272
• Device Catalogue Number: 71453272
• Device Lot Number: 19AM19355
• 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: 01/30/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2019
• 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: GII CMT TIB SIZE 1 {} RIGHT 71420176/20GM14692; GII OVAL RESURFACING PAT 29MM 71421029/21AM11466; LEGION CR NP FEM SZ 2 RT 71423212/18EM08487
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 47 KG