MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN LEGION TOTAL KNEE PRIM FEM COMP; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71423235
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arthralgia (2355); Osteolysis (2377); Fibrosis (3167); Medical device site infection (4845)
Date of Event	05/11/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
*us legal* it was reported that a revision surgery was performed on (b)(6) 2018.The revision surgery was performed due to infection.
Additional Manufacturer Narrative
The device, used for treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms per complaint details, a revision was performed on the right knee approximately 1.5 years post implantation due to infection.However, per legal correspondence, medical documentation has not been provided as of the date of this review.Based on the information provided, the root cause and/or patient outcome beyond that which was provided in the complaint itself could not be confirmed nor concluded.No further medical assessment is warranted at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-opened for further evaluation.The provided chartstiks (attached as 'new information' on (b)(6) 2021) were reviewed and appear to reflect the (b)(6) 2016 tka implantation components, which do not provide insight into the root cause of the reported event.No further clinical documentation/information has been provided to date; therefore, no change to the previous medical assessment (performed (b)(6) 2021) is warranted at this time.Should clinically relevant documentation become available in the future, this case may be re-opened/re-assessed.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This included a review of sterilization documents which indicated that the product was sterilized according to sterilization release documentation.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Infection, a potential complication associated with any surgery, can occur and possible causes could include but not limited to contamination, patient reaction, and post-operative healing issue.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.
Event or Problem Description
It was reported that a revision surgery was performed on (b)(6) 2018.The revision surgery was performed due to infection, loosening, chronic knee pain and fibrosis.During the revision, all the components were explanted.The primary right tka was performed in (b)(6) 2016 with a genesis 2 system.
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, the reported manipulation under anesthesia (mua) was done due to arthrofibrosis, which is a known complication of major knee surgeries due to excessive scar tissue formation.Therefore, it cannot be concluded the arthrofibrosis, and subsequent mua were associated with the implant.The reported chronic pain can be seen as a result of the arthrofibrosis, infection and/or loosening.As well, the reported loosening can be seen as a result of the unspecified infection.The infection is a common risk of all surgeries, is highly likely of an exogenous nature and there is no evidence the infection is related to the implant.A subsequent 2nd revision was reported due to pain and tenderness to touch; however, no further information was provided regarding this event.The known patient impact is the mua¿s and multiple revisions.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 revealed similar events for the listed device over the previous 3 years and 7 months, but no similar events for the batch based on the historical data, 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 that acute post-surgical wound infection has been identified in possible adverse effects.Active, local infection or previous intra-articular infections are identified in contraindications for total knee replacement.Additionally, 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 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.A review of the sterilization records revealed the batch was sterilized within normal parameters.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include injury, patient condition and/or medical history.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.H6: component code, type of investigation, investigation findings and investigation conclusions.

• Brand Name: UNKN LEGION TOTAL KNEE PRIM FEM COMP
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• 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 ; 1450 brooks road; memphis, TN 38116 ; 5123913905
• MDR Report Key: 11106262
• Report Number: 1020279-2021-00010
• Device Sequence Number: 3609347
• Product Code: JWH
• UDI-Device Identifier: 00885556030400
• UDI-Public: 00885556030400
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/19/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/03/2025
• Device Catalogue Number: 71423235
• Device Lot Number: 15LM04575
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 08/12/2021; 12/07/2023; 01/18/2024
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 08/13/2021; 12/13/2023; 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2015
• 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: 71420186 / LOT# F1613153; 71421516 / LOT# 15LM10832
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Sex: Female