MAUDE Adverse Event Report: SMITH & NEPHEW, INC. XR ART ISRT XLPE MED SZ3-4 RT 8MM -2DEG; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAIND,CMNTD,POLYMR/MTAL/POLYMR

Catalog Number	74023962
Medical Device Problem Codes	Mechanical Problem (1384); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Limited Mobility Of The Implanted Joint (2671)
Date of Event	11/15/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient presented right knee stiffness post right total knee arthroplasty.Even was resolved with manipulation under anesthesia.
Additional Manufacturer Narrative
(health effect - impact code & component code).Results of investigation: the device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms this case from the united states and the retrospective study for journey ii cr reports ¿stiffness post right total knee arthroplasty¿ it was treated with a manipulation under anesthesia.The outcome was: resolved and subject records were updated by site, the issue was discovered during routine reconciliation.The clinical study report forms were provided but did not reveal a cause for the stiffness.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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 risk management files and instructions for use found that the reported failure was documented appropriately.Some potential probable causes could be alignment, fit/size of device used or wear.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.Internal complaint reference: (b)(4).

• Brand Name: XR ART ISRT XLPE MED SZ3-4 RT 8MM -2DEG
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAIND,CMNTD,POLYMR/MTAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10098972
• Report Number: 1020279-2020-01892
• Device Sequence Number: 14304304
• Product Code: JWH
• UDI-Device Identifier: 00885556615980
• UDI-Public: 885556615980
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

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 Expiration Date: 08/02/2026
• Device Catalogue Number: 74023962
• Device Lot Number: 16HM03325
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/30/2020
• Initial Date Received by Manufacturer: 04/30/2020
• Supplement Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 02/09/2021
• 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