MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JII UNI TIB BASE SZ 2 RM/LL; PROST, KNEE, FEMTIB, NON-CONSTRAINED, CEMENTED, MET/POLY

Model Number	71422355
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial final mdr.Internal reference number: (b)(4).This complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, after a ukr surgery was performed on (b)(6) 2022, patient experienced medial knee pain associated with tibial component subsidence.This adverse event was identify by a clinical study on (b)(6) 2022.A revision surgery has been planned.Patient's current health status is ongoing.
Event or Problem Description
It was reported that, after a ukr surgery was performed on (b)(6) 2019, patient experienced medial knee pain associated with tibial component subsidence.This adverse event was identify by a clinical study on (b)(6) 2022.A revision surgery has been planned.Patient's current health status is ongoing.

• Brand Name: JII UNI TIB BASE SZ 2 RM/LL
• Common Device Name: PROST, KNEE, FEMTIB, NON-CONSTRAINED, CEMENTED, MET/POLY
• 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: 15895872
• Report Number: 1020279-2022-04873
• Device Sequence Number: 17457425
• Product Code: HSX
• UDI-Device Identifier: 00885556578797
• UDI-Public: 00885556578797
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K152315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2022

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: 71422355
• Device Catalogue Number: 71935200
• Device Lot Number: 18LAP0093B
• 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: 11/17/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 12/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2019
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71422355/JUNI OX FB FEM SZ 5 RM LL; 71935218 / JII UNI TIB XLPE INS / 16GAP78660A; 71935218/JII UNI TIB XLPE INS SZ 1-2 9MM RM/LL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female