MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PRESSFIT STEM 14MM X 160MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER

Model Number	71424047
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Sepsis (2067)
Date of Event	10/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a tka surgery performed on (b)(6) 2020, the legion rev tibia baseplate sz 2 right ((b)(4)) became loose due to sepsis, so on (b)(6) 2021 a revision surgery was performed to remove the legion rev tibia baseplate sz 2 right ((b)(4)), the genesis ii constrained articular insert size 1-2 18mm ((b)(4)), the legion cobalt chrome constrained femoral size 4 right ((b)(6)) and the legion pressfit stem 14mm x 160mm (b)(4)).Current health status of the patient is unknown.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.A review of the sterilization records revealed the batch was sterilized within normal parameters.A review of complaint history did not reveal similar events for the listed device.The clinical/medical evaluation concluded that based on the information provided, the clinical root cause of the reported device loosening was due to sepsis.The root cause of the unspecified sepsis infection cannot be definitively concluded.However, it was reported the ¿patient had a tooth abscess that was not treated.¿ the patient impact was reportedly sepsis, loosening of the device, and the revision.The patient¿s current health status is ¿fairly good." without the requested clinical information, further patient impact cannot be determined, and no further clinical medical assessment is warranted.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.The contribution of the device to the reported event could not be corroborated.Possible causes could include but not limited to surgical technique used, size of device or user/procedural variance (not to say user error).Infection, a potential complication associated with any surgery, can occur and possible causes could include but not limited to contamination, patient reaction, and loss of sterility.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 future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: LGN PRESSFIT STEM 14MM X 160MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER
• 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: 12796735
• Report Number: 1020279-2021-08061
• Device Sequence Number: 12192263
• Product Code: JWH
• UDI-Device Identifier: 03596010546791
• UDI-Public: 03596010546791
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K072531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2022

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 Model Number: 71424047
• Device Catalogue Number: 71424047
• Device Lot Number: 18JSM0169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2019
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown