MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II UNI MED XLPE INSERT SZ 3-4 8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 74026158

Device Problems Material Erosion (1214); Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Infiltration into Tissue (1931); Loss of Range of Motion (2032); Arthralgia (2355); Joint Laxity (4526)

Event Date 07/21/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a partial knee replacement with a journey ii system had been performed on (b)(6) 2022, the insert showed early wear and was moving as the knee was bent, causing metal on metal rubbing.Metal particles were distributed throughout the leg causing tainted tissue as well.The patient experienced pain.A revision surgery was conducted on (b)(6) 2022 to convert to tha as consequence.Current health status is not known.

Event Description

It was reported that, after a partial knee replacement with a journey uni system had been performed on (b)(6) 2022, the patient experienced increasing pain, joint laxity, stiffness, instability and popping in the right knee.A revision surgery was conducted on (b)(6) 2022 to convert to a tka.During this procedure, there was an effusion with metal debris and a black stained tissue on the majority of the synovium.The femoral condyle had a stripe of wear through the oxinium.The polyethylene insert was still locked into the tibial tray.While examining the tibial tray, there was wear into the posterior polyethylene insert and the metal.After removing these components, a synovectomy was done to remove the metal debris.The patient was taken to the recovery room in stable condition.The patient is recovering from this procedure and has been attending physical therapy 3 times a week.

Manufacturer Narrative

Corrected data: b3, b5, d10, h6 (health effect - clinical code, medical device problem code).

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, based on the documentation provided, the possible size selection and/or placement of the primary-uni tibial baseplate component cannot be ruled out as a contributing factor to the multi-symptomatic early ¿failure¿ by allowing the femoral condyle to articulate on the metallic tibial baseplate posteriorly instead of with the poly insert which remained ¿still locked into the tibial tray¿.No traumatic event was reported, and it is unknown if the tibial baseplate could have subsided or migrated as the immediate post-uni images were not provided.The patient impact includes the multi-symptoms reported, early revision/conversion to a total knee arthroplasty and the anticipated transient rehabilitation.Further patient impact could not be determined.No further medical assessment can be rendered at this time.A review of the production order 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 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 others debris which can cause abrasion of the articulating surfaces.Higher rates of wear may shorten the useful life of the prothesis, and lead to early revision surgery to replace the worn prosthetic components, this 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 that could contribute to the reported event include size selected, alignment, joint laxity, patient condition or postoperative care.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: JRNY II UNI MED XLPE INSERT SZ 3-4 8MM
• 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: 15434179
• MDR Text Key: 300028129
• Report Number: 1020279-2022-04113
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00885556677063
• UDI-Public: 00885556677063
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74026158
• Device Catalogue Number: 74026158
• Device Lot Number: 21EAP0101H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2021
• 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: JOURNEY II UNI MEDIAL TIBIA SZ 4 RIGHT, LOT#:21DAP; JRNY II UNI OX FEMORAL 4 RM/LL, LOT#:21KM05182; PN: 74026034 / LOT: 21KM05182; PN: 74026724 / LOT: 21DAP0025B
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 72 KG