MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN COCR CONSTRAINED FEM 5 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAIN, CEMENT, POLY/MET/POL

Model Number	71425005
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was opened by smith+nephew to document a patient complication identified through the review of clinical evidence from post market clinical data collection activities that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent 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 confirm a relationship between the reported event and the device or 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.(b)(4).
Event or Problem Description
It was reported that, the patient underwent a left tka revision due to aseptic loosening as primary diagnosis.Approximately twenty seven (27) months after this procedure, the patient experienced an unspecified implant dissociation of the revised knee prosthesis and required a second revision.The dates in which the index surgery, first revision and second revision took place are not known.It is also unknown which devices were explanted and/or exchanged during the second revision.This incident was identified in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing tka revision outcomes were gathered; therefore, additional information is not known.
Additional Manufacturer Narrative
Additional information: a4, b3, b5, b7, d4, d10, h4, h6.
Event or Problem Description
It was reported that patient underwent a tka left revision surgery in 2016 due to aseptic loosening.During the revision surgery, legion/gii smith & nephew component(s) were implanted.(b)(6) years after this procedure, the patient sustained an implant dissociation and required a re-revision.It is unknown which devices were explanted/exchanged during this procedure.This information was collected retrospectively as part of a post-market clinical follow up activity and is provided in an anonymized format; therefore, no further information available.
Additional Manufacturer Narrative
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, as no further information on these events will be available, a clinical root cause for the reported events cannot be confirmed.The patient impact beyond the reported revision cannot be determined with the information provided.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 did not reveal similar events for all the reported batches based on the historical data.The review did reveal similar events for the femoral component and offset couplers over the previous 12 months.For the rest of the reported part numbers, no similar events were revealed over the previous 12 months.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 warnings and precautions that repeated assembly and disassembly of the modular components could compromise a critical locking action of the components.Surgical debris must be cleaned from components before assembly.Debris inhibits the proper fit and locking of modular components which may lead to early failure of the procedure.Modular components must be assembled securely to prevent disassociation.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 evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include injury 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.

• Brand Name: LGN COCR CONSTRAINED FEM 5 LT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAIN, CEMENT, POLY/MET/POL
• 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: 16219084
• Report Number: 1020279-2023-00158
• Device Sequence Number: 18015341
• Product Code: JWH
• UDI-Device Identifier: 03596010580337
• UDI-Public: 03596010580337
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K060742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2025

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: 09/21/2025
• Device Model Number: 71425005
• Device Catalogue Number: 71425005
• Device Lot Number: 15JM16425
• 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: 01/19/2023
• Supplement Date Received by Manufacturer: 10/31/2024; 01/02/2025
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 11/06/2024; 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2015
• 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: 71421512/GII PS HI FLEX ISRT SZ 3-4 18; 71421665/LGN SCRW DIS FEM WDG SZ5 10MM; 71421743/LEGION SCW LWDG S5 10D X 5P; 71424004/LGN REV TIBIA BASE SZ 4 LT; 71424004/LGN REV TIBIA BASE SZ 4 LT; 71424025/LGN PRESSFIT STEM 12MM X 120MM; 71424028/LGN PRESSFIT STEM 15MM X 120MM; 71424223/LGN OFFSET COUPLER 2MM; 71424223/LGN OFFSET COUPLER 2MM
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 81 KG