MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 3-4 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAIND, CEMENTD, POLY/METAL/POLY

Model Number	71453214
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a s&n legion revision system had been implanted in a revision surgery, the patient experienced instability.It is unknown if the previous revision surgery was for a s&n system.A revision surgery was performed to address the adverse event: an exchange from a 15mm ps to 18mm constrained insert was done.The patient outcome is unknown.
Additional Manufacturer Narrative
H6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, a constrained insert revision/upsize (15mm to 18mm) was performed due to instability.Responses to medical documentation/information requests have not been received as of the date of this assessment.Without supporting clinical/medical documentation, the root cause could not be definitively confirmed, although reportedly it was due to instability.The patient impact beyond the reported instability and subsequent revision could not be determined; however, no patient injury or surgical delay was reported.Should relevant clinical documentation become available, this complaint may be re-evaluated.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 did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.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 not limited to fit/sizing issue, lifetime of device or patient condition.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 15MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAIND, CEMENTD, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10797061
• Report Number: 1020279-2020-06259
• Device Sequence Number: 3657312
• Product Code: JWH
• UDI-Device Identifier: 00885556035108
• UDI-Public: 00885556035108
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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: 71453214
• Device Catalogue Number: 71453214
• Device Lot Number: 17HT91856
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 79