MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HK GD MOTION ISRT 18MM SZ 2-3 LT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71423347
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint locking (2672)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, after a second tka revision surgery was performed in 2016, the patient has been complaining of pain with a mechanical blockage sensation in the area of the left knee joint for 2 months.Until then, she had been satisfied since the last operation on the left knee prosthesis in 2016.No trauma remembered.No wrong movement remembered.The patient reports that there are some blockage phenomena, but also instability in the left knee joint.The patient reports that she has been walking on a walker for a long time, in the last 2 months, however, it has become significantly worse.Now the x-ray and ct show the screw loosening of the posterior inlay screw again.A revision surgery is scheduled for an unspecified date, in which an screw thread inspection will be performed.If it is intact a replacement of mobile parts (coupling mechanism, inlay, screw) will be performed, but if it is damaged a replacement of the tibial component will take place.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation revealed that the reported x-ray and computed tomography show screw loosening of the posterior inlay screw again.The undated x-ray images have been reviewed; the lateral image shows the screw in the tibial base plate is proud.Radiolucency is noted on the anterior aspect of the tibial stem, as well as possible patella osteolysis.A revision is planned.The pain and mediolateral instability is consistent with the loosening of the screw in the tibial plateau; however, the clinical root cause of the loosened screw cannot be confirmed.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number 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 and/or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions.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.At this time, we have no evidence to conclude that the product 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, inadequate integration between the cement and bone/implant, osteolysis and/or 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.

• Brand Name: LEGION HK GD MOTION ISRT 18MM SZ 2-3 LT
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 21518082
• Report Number: 1020279-2025-00398
• Device Sequence Number: 8378475
• Product Code: KRO
• UDI-Device Identifier: 00885556030868
• UDI-Public: 885556030868
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K081111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2025

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: 10/29/2023
• Device Catalogue Number: 71423347
• Device Lot Number: 13KM24300
• 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: 02/05/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 07/02/2025
• Date Device Manufactured: 10/31/2013
• 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: LEGION HK 18MM BOLT - SLEEVE, LOT#:13CTM0008A.; LGN HK AXLE PLUG, LOT#:14JM04683.; LGN HK AXLE SZ 4 FEMUR, LOT#:08FTM0008B.; LGN HK LINK ASSY SZ 2-5 FEM, LOT#:12JBP0091.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 110 KG