MAUDE Adverse Event Report: SMITH & NEPHEW, INC. POROUS TIBIAL TRAY SIZE 2-RIGHT MEDIAL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR,

Catalog Number	1-10012-250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10.Smith & nephew, inc., has initiated a field action to voluntarily remove the engage cementless partial knee system from the market.This complaint was originally processed in the engage surgical complaint management system prior to acquisition by smith & nephew, inc.The event has been reassessed and is being retrospectively reported in association with the field action.Additionally, the investigation of this incident previously conducted by engage surgical has been re-opened for review.A supplemental report will be provided upon completion of further investigation activities by smith & nephew, inc.
Event or Problem Description
It was reported that, six months after unicompartmental knee arthroplasty was performed on an unknown date, the patient experienced pain.This adverse event was treated with a revision surgery to tka on (b)(6)2021.An abnormally high posterior slope of 19 degrees (the standard is 5 degrees) was produced upon tibial resection, which is the probable root cause the reported pain.Patient's current health status is unknown.
Additional Manufacturer Narrative
H3, h6: results of investigation: it was reported that a surgical resident was allowed to perform the tibial resection step on the patient.The surgical resident had not been trained on the proper engage surgical technique or use of the instruments and was not certified by engage to use the system.The attending surgeon reported that a very ¿aggressive¿ tibial cut was made by the resident at the time of surgery.Postop x-ray revealed a super-physiologic posterior slope of 19 deg was measured when used properly the instruments produce a 5 deg nominal posterior slope, which has been shown to be clinically successful in other partial knee replacement systems.An abnormally high posterior slope would lead to elevated tibial strains being introduced into the bone as well as additional stresses being applied to the acl.The x-rays revealed no failure or malfunction of the device.Devices appear well-approximated to the bone with normal in-growth evident at 7-mo on ct evaluation.There was no injury to the patient related to the device, as the revision was due to use by an un-trained user.The patient was successfully revised to a tka at 8-months post-op.The surgeon and rep reported that the implants were well-fixed to the bone prior to removal.Investigation update: as correction action a voluntary market removal will be performed for the engage cementless partial knee system due recent complaint data that indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Based on this investigation, the need for corrective action may be indicated.

• Brand Name: POROUS TIBIAL TRAY SIZE 2-RIGHT MEDIAL
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR,
• 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: 17014940
• Report Number: 1020279-2023-01159
• Device Sequence Number: 7031748
• Product Code: NJD
• UDI-Device Identifier: 00885556873144
• UDI-Public: 885556873144
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K190439
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2023

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: 03/09/2025
• Device Catalogue Number: 1-10012-250
• Device Lot Number: 100048
• 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: 04/27/2023
• Supplement Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2020
• 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: A
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 92286
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female