MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN LEGION TOTAL KNEE REV FEM COMP; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNKN01200225

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Autoimmune Disorder (1732); Cyst(s) (1800); Failure of Implant (1924); Loss of Range of Motion (2032); Ambulation Difficulties (2544); Inadequate Osseointegration (2646); Unspecified Immune System Problem (4435); Hormonal Imbalance (4495); Swelling/ Edema (4577)

Event Date 02/02/2019

Event Type  Injury  

Event Description

*(b)(6) legal case* it was reported that, after a revision surgery had been performed on the patient's right knee on (b)(6) 2019, the patient experienced loosening of the joint.It is unknown if an additional revision surgery has been scheduled yet to treat this adverse event.The patient's outcome is unknown.

Manufacturer Narrative

Additional information was received that identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.

Manufacturer Narrative

Based on new information received, this case is deemed reportable.

Event Description

All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Additional information identified that this event is a duplicate of (b)(6), with the related cases: (b)(6).The reassessment determined that the issue does not meet the threshold for reporting and is a duplicate.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.

Event Description

It was reported that, after a revision surgery had been performed on the patient's right knee on (b)(6) 2019 due to metallosis, the patient states she has been experienced loosening of the joint, swelling, misalignment, restricted mobility, ambulation difficulties, elevated zirconium levels in blood, large spleen, kidney cysts and the continuousness of several hormonal and autoimmune complications related to cushing¿s and hashimoto¿s syndrome.The patient's stated that she received medical advice and, in order to treat the implant loosening, either an insert exchange or conversion to a hinge type system is required for her right knee.It is unknown if the additional revision surgery has been scheduled yet.Details on the treatment for the rest of the reported symptoms experienced by the patient are unknown.

Manufacturer Narrative

Further assessment of this incident has been conducted and it was determined that this is not a duplicated record as previously stated within the supplemental report #3 for mdr reference 1020279-2021-05962.Please find below our investigation findings.Related complaint (internal reference):(b)(4).Associated medwatch number: mw5109699 additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the device was not returned for evaluation.The pictures provided were reviewed and could not confirm the loosening of the joint, swelling, misalignment, restricted mobility, ambulation difficulties, large spleen, kidney cysts and the continuousness of several hormonal and autoimmune complications.The clinical/medical investigation concluded the most recent provided x-rays (illegible date due to distortion upon enlargement) compared to the single post revision ap image (3.Feb.2019) confirm the revision with a long-stemmed knee system; however, cannot identify a root cause for the reported loosening which either another ¿revision and/or conversion to a hinge-type¿ knee system was recommended.The clinical root cause of the reported loosening cannot be concluded; however, the loosening along with the patient¿s known comorbidities, prior metallic tissue debris and loss of vastus medians muscle and lateral side laxity documented 5 weeks post revision could not be ruled out as possible contributing factors to the multiple symptoms reported.Recently communicated via email: ¿and now revision spire bristol catastrophic failure re laxitity¿ hospitalized re: 10x4cm laceration external and internal.Debridement.2.2 week inpatient trauma co cwmbran¿.However, without medical documentation, definitive clinical factors which could have contributed to the reported event could not be fully assessed nor concluded.The patient impact beyond that which has been reported along with the alleged multiple symptoms cannot be determined.No further medical assessment can be rendered at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, lack of ingrowth, traumatic injury, joint tightness, patient reaction, surgical technique used, user/procedural variance and/or patient condition.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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.Corrected data: b5, h6 (health effect - clinical code, health effect - impact code).

• Brand Name: UNKN LEGION TOTAL KNEE REV FEM COMP
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-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: 12167937
• MDR Text Key: 261542249
• Report Number: 1020279-2021-05962
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01200225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female