MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION CON ART INS 9MM SZ 7-8; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71420551
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Nerve Damage (1979); Rupture (2208); Subluxation (4525); Joint Laxity (4526)
Date of Event	06/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Corrected data: h3 (device analysis performed), h6 (type of investigation, investigation findings, investigation conclusions).Updated results of investigation: the associated device was returned and evaluated.The visual inspection revealed scratches and deep gouges on the surface of the device.This inspection was conducted using a magnifying glass.A dimensional evaluation performed on the device revealed damage that appears to be from attempted use and has the potential to cause an event during attempted mating to the tibial base as described in the complaint.The damage/deformation of several features would not allow for accurate measurement.All measurable critical features that could be measured were within specification.The dimensional inspection of the returned device did not indicate the product was defective at the time of shipment from the manufacturing site.This device is subjected to multiple visual and dimensional inspection during processing, and this type of damage has a high likelihood of detection during these inspections.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 dislocation and subluxation 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.This has been identified as a possible adverse effect.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 traumatic injury, patient condition, postoperative care or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Should 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.
Additional Manufacturer Narrative
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 conservatively submitting this report in accordance with applicable regulations.If additional 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 undergoing a tka on an unknown date, patient experienced insert detachment from the tibial component.In addition, there was luxation.This adverse event was addressed by conducting revision surgery on (b)(6) 2014, to exchange the legion con art ins 9mm sz 7-8.Patient's current health status is unknown.
Event or Problem Description
It was reported that, after undergoing a tka on (b)(6) 2024, patient experienced insert detachment from the tibial component.In addition, there was a rupture of the extensor apparatus with a knee luxation and vascular nerve damage.This adverse event was addressed by conducting revision surgery on (b)(6) 2014, to exchange the legion con art ins 9mm sz 7-8.Patient's current health status is unknown.
Additional Manufacturer Narrative
Additional information: a2 (subject age), d6a (implantation date).Corrected data: b5 (narrative updated), d9 (sample received), e4 (surgeon did not inform fda), h3 (analysis is expected).

• Brand Name: LEGION CON ART INS 9MM SZ 7-8
• 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: 19745297
• Report Number: 1020279-2024-01379
• Device Sequence Number: 6491365
• Product Code: JWH
• UDI-Device Identifier: 03596010555830
• UDI-Public: 03596010555830
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K962137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2024

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 Catalogue Number: 71420551
• Device Lot Number: 22BM06233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 07/05/2024; 08/05/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 07/18/2024; 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• 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 Age: 67 YR
• Patient Sex: Male