MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JUNI OX FB FEM SZ 6 LM RL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71422346

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 04/13/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a partial knee replacement surgery performed on (b)(6) 2019, the patient experienced a lateral osteochondral lesion.This situation was addressed via revision surgery on (b)(6) 2021.The patient is recovering.

Manufacturer Narrative

H3 ,h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, a clinical study patient required a left medial uni-revision/conversion to a tka approximately 22 months post implantation.The provided 1-year-visit documentation (datafax #157, plate#006) did not show any radiolucencies or new adverse events.The severe, non-serious ae(#1) which was possibly due to the study device and/or study procedure was detailed as progression oa lateral compartment of left knee with pain which required hospitalization (prolonged) and revision with admission (b)(6) 2021 to discharge on (b)(6) 2021.The provided brief op-note surgical diagnosis is ¿pmg removal and ptg implant to the left¿ with the known diagnosis as ¿pmg aseptic loosening on the left¿ and detailed ¿poor integration of the medial hemipiat¿.Reportedly, although the patient was ¿recovering/resolving¿, study participation was discontinued due to the event (as competitor components used in revision).It was communicated that 2-year x-rays were not taken.Reportedly, the root cause of the event was disease progression which is a known potential occurrence and does not support a component malperformance.Although the patient was reportedly ¿recovering¿, the patient impact beyond the reported pain, disease progression, and revision/conversion with the hospitalization course could not be determined.No further medical assessment can be rendered at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed that loosening, dislocation, subluxation, excessive rotation, flexion contracture, decreased range of motion, lengthening or shortening of the leg, looseness of components, unusual stress concentrations and extraneous bone has been identified as possible adverse effects.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, disease progression and/or patient condition.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JUNI OX FB FEM SZ 6 LM RL
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 14161818
• MDR Text Key: 289666758
• Report Number: 1020279-2022-01884
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010629777
• UDI-Public: 03596010629777
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K073175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71422346
• Device Catalogue Number: 71422346
• Device Lot Number: 19DM01109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: JII UNI TIB BASE SZ 6 LM/RL-18BAP0022C; JII UNI TIB XLPE INS SZ 5-6 8MM LM/RL-18JAP0035B
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male