MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S1-2RM/LL8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71422352

Device Problems Material Fragmentation (1261); Biocompatibility (2886)

Patient Problems Discomfort (2330); Metal Related Pathology (4530)

Event Date 06/16/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a uka surgery was performed on (b)(6) 2021, the patient experienced feeling of wrongness.Consequently, a revision surgery was performed on (b)(6) 2023 in response to this adverse event, during which metallosis was observed as a result of abnormal wear of the juni ox fb fem sz 2 rm ll, so it was exchanged for competitor device.Patient's current health status is unknown.

Event Description

It was reported that, after a uka surgery was performed on (b)(6) 2021, the patient experienced feeling of wrongness.A revision surgery was performed on (b)(6) 2023 in response to this adverse event, during which metallosis was observed as a result of an abnormal wear/fragmentation of the journey uni tibinrt s1-2rm/ll8mm and a consequential wear of the juni ox fb fem sz 2 rm ll.The whole system was exchanged for a competitor's.Currently the patient is not in bad condition, but has a little noise in the knee.

Manufacturer Narrative

Additional information: a3, b7, d4 (expiration date), h4 corrected data: b5, d1, d4 (catalog number, lot number, unique identifier (udi) #), d10, g3/g4 (510k number), h6 (medical device problem code).

Manufacturer Narrative

The associated devices were returned and evaluated.A visual inspection of the returned uni insert reveals signs of extreme wear.There is discoloration, breakage on the end of the device and deep gouges.The visual of the uni tibial base reveals scratches throughout the device and signs of extreme wear.The additional returned device, part number is covered by dried bone cement, reveals deep gouges, scratches and extreme wear in the device.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.The clinical/medical evaluation concluded that this case reports approximately two years post implantation a revision unicompartmental knee arthroplasty.The three provided photos confirm the reported black material intraoperatively as well as the worn insert and femoral component.However, the photos alone do not add to the clinical investigation of the reported metallosis and wear of the components.It has been reported that further information is not available.Therefore, there were no clinical factors found which would have contributed to the reported events.It has been reported that the patient is not in bad condition but has a little noise in the knee.No further clinical 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.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file 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.A review of the instructions for use was performed, and the knee systems reveal in possible adverse effects that wear of the polyethylene articulating surfaces of knee replacement components has been reported following total knee replacement.Higher rates of 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.Factors that could contribute to the reported event include implant corrosion, irregular implant interaction, wear, abnormal motion over time or patient condition.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.We consider this investigation closed.

• Brand Name: JOURNEY UNI TIBINRT S1-2RM/LL8MM
• 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: 17249381
• MDR Text Key: 318345141
• Report Number: 1020279-2023-01400
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010582089
• UDI-Public: 03596010582089
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71422352
• Device Catalogue Number: 71422245
• Device Lot Number: 19EM08938
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2019
• 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: 71422245/ JOURNEY UNI TIBINRT S1-2RM/LL8MM; 71422352/19DM27123/JUNI OX FB FEM SZ 2 RM LL; 71422432/20EM06063/JRNY UNI TIBIAL BASE RM/LL SZ 2
• Patient Outcome(s): Required Intervention
• Patient Sex: Female