MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 3-4 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71453212
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka had been performed on (b)(6) 2020, the patient underwent a revision surgery on (b)(6) 2022, in which the lgn ps high flex xlpe sz 3-4 11mm was removed and replaced with legion revision.The reason for the revision surgery is unknown.The patient current health status is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a tka had been performed on (b)(6) 2020, the patient underwent a revision surgery on (b)(6) 2022, in which the lgn ps high flex xlpe sz 3-4 11mm was removed and replaced with legion revision.The reason for the revision surgery is unknown.The patient current health status is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
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, a tka revision was performed approximately 1.5 years post implantation due to unspecified reasons.Reportedly, the well-fixed femoral and tibial components were removed and replaced with a legion revision, along with the articulating insert.It was communicated that the requested documentation was not available.Without the requested documentation/information, the root cause of the reported revision could not be definitively concluded.The patient impact beyond the reported tka revision cannot be determined.The current patient status remains unknown.No further medical assessment can be rendered at this time.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 revealed similar events for the listed device over the previous 12 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 risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of the instructions for use for this device provides complete guidelines of indications, contraindications, warnings and precautions and possible adverse effects that may occur preoperative, during surgery or postoperative.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.No details of the alleged fault, malfunction or injury were provided, therefore no probable cause can be delineated.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.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 3-4 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 13502038
• Report Number: 1020279-2022-00616
• Device Sequence Number: 14451004
• Product Code: JWH
• UDI-Device Identifier: 00885556034170
• UDI-Public: 00885556034170
• 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: 2020
• Device Explanted Year: 2022
• 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): 03/15/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71453212
• Device Catalogue Number: 71453212
• Device Lot Number: 19HM04695
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2022
• Supplement Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 03/15/2022
• Date Device Manufactured: 08/06/2019
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown