MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 5-6 11MM; PROST, KNEE, PATFEMTIB, SEMI-CNSTRND, CMNTD, POLY/MET/POLY

Model Number	71453222
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	12/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
It was reported that, after a second tka surgery had been performed on (b)(6) 2021, patient had an infection of the knee.The adverse event was addressed with a revision surgery on (b)(6) 2021 to replace the lgn ps high flex xlpe sz 5-6 11mm.The condition of the patient is unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that without the requested information, the root cause of the knee infection cannot be definitively concluded.The patient impact beyond the reported infection and revision cannot be determined and the patient current status remains unknown.No further medical assessment can be rendered.A review of the manufacturing records 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 risk management file and instructions for use documents revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of the sterilization records revealed the batch was sterilized within normal parameters.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but are not limited to contamination, patient reaction, and post-operative healing issue.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.(b)(4).

• Brand Name: LGN PS HIGH FLEX XLPE SZ 5-6 11MM
• Common Device Name: PROST, KNEE, PATFEMTIB, SEMI-CNSTRND, CMNTD, POLY/MET/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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13111243
• Report Number: 1020279-2021-08943
• Device Sequence Number: 3536936
• Product Code: JWH
• UDI-Device Identifier: 00885556035351
• UDI-Public: 00885556035351
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2022

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: 71453222
• Device Catalogue Number: 71453222
• Device Lot Number: 19JM13117
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2021
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown