MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TIBIAL ANCHOR STEM SIZE 5-6; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR,

Catalog Number	1-10011-300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	06/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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, after uka surgery was performed on (b)(6) 2021, ap x-rays demonstrated tibial collapse where tibial implant was rotated in valgus.This adverse event was treated with revision surgery on (b)(6) 2021 (5 weeks post-op) from a uka to tka.During this procedure, it was observed that the bone quality was very poor.It was determined that a cemented total knee arthroplasty should have been performed instead as initial surgery, since the patient was not a good candidate for a uka.The surgeon was able to lift the tibial tray & anchor out of the patient with a rongeur by hand.Revision procedure from uka to tka was successfully completed.Based on the information provided by 3 independent individuals, including 2 trained orthopedic medical doctors, the cause of the incident was poor bone quality of the patient, and the device did not cause or contribute to the incident.
Additional Manufacturer Narrative
Results of investigation: investigation of the incident included correspondence with the operative surgeon, the sales rep, and engage personnel each who attended the revision surgery.Poor bone quality was identified as the root cause of the tibial collapse.He stated that patient was not a good candidate for a uka procedure due to patient comorbidities and that he should have instead done a cemented total knee replacement in the original surgery.It was also stated in a phone call on 6/4 (day of revision surgery) that bone was extremely soft and concurred that it was the cause of the failure.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: TIBIAL ANCHOR STEM SIZE 5-6
• 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: 17014788
• Report Number: 1020279-2023-01155
• Device Sequence Number: 7538649
• Product Code: NJD
• UDI-Device Identifier: 00885556873106
• UDI-Public: 885556873106
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K190439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2023

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: 01/05/2026
• Device Catalogue Number: 1-10011-300
• Device Lot Number: 100074
• 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: 06/22/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 92286, Z-1671-2023
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: 1-10012-600/ LN: 100057; PN: 1-10013-609/ LN: 100209
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 74 KG