MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S1-2LM/RL8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71422241

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 09/22/2023

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that, after an uka surgery had been performed on an unspecified date, the journey uni tibinrt s1-2lm/rl8mm dislocated forward during a lunge.It is unknown how this incident has been addressed thus far and so is the patient's current health status.

Event Description

It was reported that, after an uka revision surgery had been performed on (b)(6) 2023 (reported under your reference number: 1020279-2023-02290), the journey uni tib inrt s1-2lm/rl8mm dislocated forward during a lunge.A revision surgery was performed on (b)(6) 2023 to address the issue.Upon intra-op inspection, the following findings were noted: (i) femoral component is completely scratched in the dorsal part; therefore, it was decided to remove it; (ii) although there was no obvious damage to the tibial component, the inlay can no longer be fully inserted; therefore, removal of the tibial component.A new journey uni system was used to replace the explanted construct.The patient was discharged on (b)(6) 2023 with wound treatment, prophylactic medication, indications for physical exercise, and follow-up x-ray examinations.

Manufacturer Narrative

Section h10: the associated devices were returned and evaluated.A visual inspection of the returned devices reveals the discoloration on the insert, scratches on the femoral component and bone cement still on the device.All the devices, including the tibial baseplate, show signs of wear and use.The clinical/medical evaluation concluded that with the information provided a procedural variance and/or the reported ¿forward lunge,¿ cannot be ruled out as possible contributing factors to the reported inlay dislocation and subsequent revision as trauma can contribute to ligament injury.The patient impact is the associated symptoms and treatment of the dislocation along with the revision of the inlay, tibial and femoral component.No further assessment is warranted at this time.For the insert, review of complaint history revealed a similar event for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.For the femoral component, 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 instructions for use for knee systems revealed in possible adverse effects that dislocation and subluxation can result from trauma, improper implant selection, improper implant positioning, improper fixation, and/or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions.In addition, wear may be initiated by particles of cement, metal, or other debris which can cause abrasion of the articulating surfaces.Higher rates of wear may shorten the useful life of the prosthesis, and lead to early revision surgery to replace the worn prosthetic components.A review of the risk management and information for use files revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.Factors that could contribute to the reported event include traumatic injury, patient anatomy, postoperative care, abnormal loading of limb, procedural variance and/or the reported ¿forward lunge¿.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.

Manufacturer Narrative

Corrected data: updated results of investigation.The associated devices were returned and evaluated.The visual inspection revealed the discoloration on the insert, scratches on the femoral component and bone cement still on the device.All the devices, including the tibial baseplate, show signs of wear and use.The clinical/medical investigation concluded that, the provided pre-revision x-rays, were reviewed and demonstrate an anterior shadow consistent with the dislocated insert.The revision operative report noted, ¿the inlay is completely dislocated forward.It can be seen that damage in this area has already occurred due to increased wear and tear with the oxinium prosthesis in place.¿ patient had a second revision 2-months after the first revision.Pre-revision x-rays, showed decreased joint space as well as the shadow consistent with the dislocated insert it was reported, ¿in lunge, inlay dislocated forward.¿ however, the operative report (op) noted indication was, ¿spontaneous inlay dislocations.¿ the op report noted, ¿during the inspection, the femoral component is completely scratched in the dorsal part.¿ the tibial, femoral and inlay were revised.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.With the information provided a procedural variance and/or the reported ¿forward lunge,¿ cannot be ruled out as possible contributing factors to the reported inlay dislocation and subsequent revision as trauma can contribute to ligament injury.The patient impact is the associated symptoms and treatment of the dislocation along with the revision of the inlay, tibial and femoral component.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the insert, a review of complaint history revealed similar events for the listed device over 12 months, but no similar events for the batch based on the historical data.For the femoral component, a review of complaint history for the part number over 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.For the baseplate, a review of complaint history based on the historical data revealed a similar event for the listed batch.This failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for knee systems revealed in possible adverse effects that dislocation and subluxation can result from trauma, improper implant selection, improper implant positioning, improper fixation, and/or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions.This document provides complete guidelines of indications, contraindications, warnings and precautions and possible adverse effects that may occur preoperative, during surgery or post operative.A review of the risk management files 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 these products and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, patient condition, postoperative care, size selected or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Should 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: JOURNEY UNI TIBINRT S1-2LM/RL8MM
• 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: 18029125
• MDR Text Key: 326846104
• Report Number: 1020279-2023-02062
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K061011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71422241
• Device Lot Number: 19DM08071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2019
• 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: FEMORAL COMPONENT (PN: 71422343/ LN: 23AM09022); JRNY TIBIAL BASE (PN: 71422422/ LN: 19CM13783)
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 69 KG