MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OXINIUM FEM SIZE 7 LEFT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71420146
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	02/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, patient had a total knee replacement 3 year ago.Patient suffered from a stiff knee and limited range of motion 20 degree - 90 degree and overstuffed patella femoral joint, therefore patient had a revision surgery, where surgeon removed the patella, femoral, tibial insert and tibial baseplate from primary surgery.Surgeon noticed the patella was not resected enough, which cause over stuffing.Surgeon achieved a range of motion from 0 degrees - 120 degrees range of motion.Patient outcome is unknown.
Additional Manufacturer Narrative
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 reports a revision surgery was performed due to limited rom and an overstuffed patella.Per email correspondence, the requested surgical reports and x-rays are not available.Therefore, the patient impact beyond the revision cannot be determined.Due to the limited information provided, a thorough assessment cannot be rendered.Should additional clinically relevant documentation become available, the clinical/medical task may be re-evaluated.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.Internal complaint reference number: (b)(4).

• Brand Name: GII OXINIUM FEM SIZE 7 LEFT
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11408614
• Report Number: 1020279-2021-01782
• Device Sequence Number: 19718913
• Product Code: JWH
• UDI-Device Identifier: 03596010439413
• UDI-Public: 03596010439413
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2021

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: 71420146
• Device Catalogue Number: 71420140
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 02/08/2021; 03/29/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 03/04/2021; 04/07/2021
• 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