MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 5-6 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71453185
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tkr had been performed in (b)(6) 2021, the patient experienced knee instability.Therefore, a revision surgery was performed on (b)(6) 2021, and it was confirmed that the knee was unstable.This adverse event was solved by changing the insert (lgn cr high flex xlpe sz 5-6 10mm) by a 5mm deep dished insert.The patella was also resurfaced and a 32mm patella insert was used.Patient current health status is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, it was reported a tkr had been performed in (b)(6) 2021.During the primary surgery, navio was abandoned as landmarks were not able to be located due to patient being morbidly obese.A revision surgery was performed on (b)(6) 2021.It was confirmed that the knee was unstable.It is noted no medical records are available.Smith and nephew has not received the explanted device and/or adequate materials to fully evaluate the complaint.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode.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 are not limited to 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 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: 12316526
• Report Number: 1020279-2021-06339
• Device Sequence Number: 3839757
• Product Code: JWH
• UDI-Device Identifier: 00885556487440
• UDI-Public: 00885556487440
• 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
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2021

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 Model Number: 71453185
• Device Catalogue Number: 71453185
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 09/17/2021
• 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 Age: 68 YR