MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 5-6 11MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER

Model Number	71453122
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a thr was performed, the patient experienced instability.This adverse event was solved by a revision surgery on (b)(6) 2021, in which a lgn cr high flex xlpe sz 5-6 11mm was explanted and exchanged.Current health status of patient is unknown.
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Additional Manufacturer Narrative
The associated device was not returned for evaluation and the reported event could not be confirmed, therefore, the contribution of the device to the reported event could not be corroborated.The clinical/medical investigation concluded that, per case details, the patient experienced instability and a revision after a primary tka on an unspecified date.The patient¿s current health status is unknown and no additional clinically relevant information was provided.Without the additional requested clinically relevant information for evaluation, the root cause of the reported instability cannot be definitively concluded.Reportedly, there was ¿no harm to patient¿.The patient¿s current health status was not provided.The patient impact beyond the reported instability and revision cannot be determined and no further medical assessment could be rendered at this time.A review of complaint history did not reveal similar events for the listed device.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.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review concluded that there are no prior escalated actions applicable related to this part number and failure mode.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 CR HIGH FLEX XLPE SZ 5-6 11MM
• 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: 13087668
• Report Number: 1020279-2021-08849
• Device Sequence Number: 5926049
• Product Code: JWH
• UDI-Device Identifier: 00885556035139
• UDI-Public: 00885556035139
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2022

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 Expiration Date: 08/09/2024
• Device Model Number: 71453122
• Device Catalogue Number: 71453122
• Device Lot Number: 14HM08245
• 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: 12/06/2021
• Supplement Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 12/27/2021
• Supplement Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2014
• 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
• Patient Sex: Unknown