MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TIBIAL INSERT SIZE 5-RIGHT MED 10MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR,

Catalog Number	1-10013-560
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/19/2021
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 a partial knee replacement surgery performed on (b)(6) 2021, the patient reported weight bearing pain at the joint line 6 months post-op.Surgeon recommended patient to wait as prior experience and literature suggests that pain would resolve as implants settled in over time.Patient was reportedly not willing to wait and opted for a revision to a tka.Surgeon noted that her long limb alignment post-surgery was ¿not that great¿.Patient was successfully converted to a cemented primary tka on (b)(6) 2021 with no augments and minimal bone loss due to the revision procedure.Also, surgeon noted that patient may not have been a good candidate for cementless uka as she had a tibia vara deformity in her left tibia they may have contributed to her pain.
Additional Manufacturer Narrative
H3, h6.Engage partial knee system instructions for use specifies the following contraindications: unicompartmental replacement is contraindicated in patients who have permanent valgus or varus deformity that requires correction for the knee to function satisfactorily post-op.Prerequisites for partial knee replacement include: unicompartmental disease with a correctable deformity with minimal to no ligament releases note: tibia vara is not considered a ¿correctable deformity,¿ thus this patient is contraindicated.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 INSERT SIZE 5-RIGHT MED 10MM
• 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: 17011704
• Report Number: 1020279-2023-01150
• Device Sequence Number: 6928534
• Product Code: NJD
• UDI-Device Identifier: 00885556873892
• UDI-Public: 885556873892
• 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,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?: No
• Is this a Product Problem Report?: No
• Device Expiration Date: 03/09/2025
• Device Catalogue Number: 1-10013-560
• Device Lot Number: 100100
• 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: 05/25/2023
• 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
• Date Device Manufactured: 03/09/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 184 KG