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 Code	Pain (1994)
Date of Event	09/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, 6 months after unicompartmental knee arthroplasty was performed on an unknown date, the patient experienced pain.This adverse event was treated with revision surgery from cementless uka to cemented uka on (b)(6) 2021.The implants were removed without issue and there was no reported damage to the implants.Patient's current health status is unknown.
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.
Additional Manufacturer Narrative
Result of investigation: x-rays show well-aligned implants that are well-approximated to the bone.It was reported that there was no sign of infection or disruption.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: 17011178
• Report Number: 1020279-2023-01142
• Device Sequence Number: 15344966
• Product Code: NJD
• UDI-Device Identifier: 00885556873106
• UDI-Public: 885556873106
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2023

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: 1-10011-300
• Device Lot Number: 100071
• 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: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.2MM SHRT PIN(PN:1-50100-230,LN:200037); 3.2MM THRDD PIN(PN:1-50100-455,LN:200038); 3.2MM THRDD PIN(PN:1-50100-455,LN:200225); PRS FMRL CMP SZ5 LFT MDL(PN:1-10003-510,LN:100018); PRS TBL TRY SZ 5-LFT MDL(PN:1-10012-500,LN:100045); TBL INSRT SZ5-LFT MD 9MM(PN:1-10013-509,LN:100130)
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 96 KG