MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE LT SZ 1-2 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74025621
Medical Device Problem Codes	Degraded (1153); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374); Joint Laxity (4526); Insufficient Information (4580)
Date of Event	11/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after tka surgery had been performed on (b)(6) 2023, the patient experienced an accelerated wear through the entire medial side of the bearing in less than one year time and when revised it was metal on metal.This adverse event was treated by revision surgery on (b)(6) 2024, in which device was explanted.Current health status of patient is unknown.
Additional Manufacturer Narrative
Internal reference number: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known inherent device and/or 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 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 submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
Additional information: a2, a4, b5, b7, d10, h6 (health effect - clinical code) the g3 value previously communicated in the first submission associated to this report (1020279-2025-00098) and dated 10-jan-2025 should have been 20-nov-2024 instead of 20-dec-2024.
Event or Problem Description
It was reported that, after a tka surgery had been performed on (b)(6) 2023, the patient was evaluated on (b)(6) 2024 and reported she had hit her knee on something in the middle of the night in early september.She had increasing pain since the incident.Xrays were obtained which revealed lateral subluxation of the tibial component and genu varus.Ct and mr arthrogram were obtained.The patient experienced pain and instability while bearing weight.The surgeon noticed an accelerated wear through the entire medial side of the bearing in less than one year time and when revised it was metal on metal.This adverse event was treated by revision surgery on (b)(6) 2024, in which the jrny ii cr isrt xlpe lt sz 1-2 9mm was explanted.Current health status of patient is good.
Additional Manufacturer Narrative
Additional information: h6 (medical device problem code, type of investigation, investigation findings and investigation conclusions), h10 (roi) h3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, based on the limited information provided the clinical root cause of the reported event cannot be confirmed.The provided images were reviewed and confirm the reported lateral subluxation of the tibial component and genu varus.The accelerated wear through the entire medial side of the bearing is consistent with the lateral subluxation of the tibial component and genu varus.The impact of the traumatic knee injury on her pain and clinical status cannot be confirmed.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 postoperative patient care and directions and warnings to patients by physicians are extremely important.Protected weight bearing with external support is recommended for a period of time to allow healing.Normal daily activity may be resumed at the physician¿s direction.Also, warnings and precautions states that the patient should be warned of surgical risks and made aware of possible adverse effects.The patient should be warned that the implant can become damaged as a result of strenuous activity or trauma.Besides, possible adverse effects section states that temporary or permanent nerve damage can result in pain or numbness of the affected limb.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 evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include injury, patient condition, postoperative care, friction and/or joint tightness.Based on this investigation, the need for corrective action is not indicated.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.H6 (health effect - clinical code).

• Brand Name: JRNY II CR ISRT XLPE LT SZ 1-2 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 21126451
• Report Number: 1020279-2025-00098
• Device Sequence Number: 15161047
• Product Code: JWH
• UDI-Device Identifier: 00885556422670
• UDI-Public: 885556422670
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 74025621
• Device Lot Number: 19DM17574
• 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: 12/20/2024
• Supplement Date Received by Manufacturer: 01/10/2025; 02/07/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 01/16/2025; 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2019
• 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: ALEVE, ATORVASTATIN 10MG AND 20MG, GABAPENTIN 300M
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 80 KG