MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN POR CR HA FEM SZ 4 LT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	71425204
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Subluxation (4525)
Date of Event	03/10/2023
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 that had been performed on (b)(6) 2014, the patient experienced a possible laxity of the mcl and had hot spots on the tibia.This was treated via a revision surgery on (b)(6) 2023, in which the implanted lgn por cr ha fem sz 4 lt, lgn cr high flex xlpe and gns ii cmt tib size 2 left were explanted.During the same revision surgery it was noticed that a subluxation of the femur was causing wear medially on the polymer insert and tibial tray.Current health status of patient is unknown, no information regarding the patient is available.
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 the requested clinical documentation has not been provided for evaluation.It has been communicated via e-mail that no further patient information is available.Therefore, there were no clinical factors found which would have contributed to the reported event.The patient impact beyond the revision surgery could not be determined.No further clinical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A review of the production orders 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 device.A review of the instructions for use documents for knee systems revealed that looseness of components 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 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.Factors that could contribute to the reported event include abnormal motion over time, bone degeneration, size selected, loss of ingrowth, osteolysis and/or traumatic injury.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 POR CR HA FEM SZ 4 LT
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: 16663652
• Report Number: 1020279-2023-00748
• Device Sequence Number: 15099714
• Product Code: MBH
• UDI-Device Identifier: 00885556108581
• UDI-Public: 00885556108581
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K091543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2023

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 Expiration Date: 01/26/2024
• Device Model Number: 71425204
• Device Catalogue Number: 71425204
• Device Lot Number: 13CHA0003A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2014
• 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: 71420162 / LOT: 13KT36235; PN: 71453103 / LOT: 10GM09955
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown