MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 7-8 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71453177
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	06/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka surgery had been performed on (b)(6) 2018 at the (b)(6) hospital the patient experienced instability.This adverse event was treated by an exchange of the legion ps high flex xlpe size 7-8 10mm ,patella was lose and revised on (b)(6) 2021 on the (b)(6) hospital.Current health status is unknown.
Additional Manufacturer Narrative
G3, h2,h3 and 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, the responses to clinical requests were not provided, therefore, s+n has not received the adequate documentation to fully evaluate the root cause of the reported instability.Based on the information provided, this adverse event was treated by an exchange of the legion ps high flex xlpe size 7-8 10mm, the patella was loose and revised.The impact to the patient beyond that which has already been reported could not be determined.Therefore, no further clinical/medical assessment is warranted at this time.Should clinically relevant documentation/information become available, the clinical task may be re-assessed.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 7-8 10MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12144750
• Report Number: 1020279-2021-05874
• Device Sequence Number: 3976111
• Product Code: JWH
• UDI-Device Identifier: 00885556487143
• UDI-Public: 00885556487143
• 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: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2024
• Device Model Number: 71453177
• Device Catalogue Number: 71453177
• Device Lot Number: 14KM10730
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKN LEGION TOTAL KNEE RESURFACING PAT COMP/UNK
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 138