MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4-RT 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74027231
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	11/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case- (b)(4).
Event or Problem Description
It was reported that, after a bilateral tka surgery had been performed on (b)(6) 2022, in (b)(6) 2023 a dislocation occurred, the patient fell while standing up.Two weeks later a closed reduction was performed and another fall and dislocation occurred the same night.One week later another closed reduction was performed.At last, this adverse event was solved with a revision surgery on (b)(6) 2023, in which it was found that the post of the jrny ii bcs xlpe art isrt sz 3-4-rt 9mm was broken off so it was exchanged.The surgeon stated that the breakage of the insert was due to second fall and dislocation.Current health status of patient is unknown.
Additional Manufacturer Narrative
H10: h3, h6: the reported event was analyzed.Although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the journey ii bcs xlpe articular insert sz 3-4 right 9mm.Therefore, no investigation is deemed for the other device.The associated device was returned and evaluated.The visual inspection revealed that the post is fractured off, the device has multiple gouges and is discolored.A dimensional evaluation performed on the device revealed that the device has damage that appears to be from attempted use and has the potential to cause an event during attempted mating to the tibial base as described in the complaint.The damage/deformation of several features would not allow for accurate measurement.All measurable critical features that could be measured were within specification.The dimensional inspection of the returned device did not indicate the product was defective at the time of shipment from the manufacturing site.This device is subjected to multiple visual and dimensional inspections during processing, and this type of damage has a high likelihood of detection during these inspections.The clinical/medical investigation stated that the two provided (unlabeled/undated) intraoperative photos confirm a post insert breakage.No additional supporting documentation has been provided.Based on the information provided the clinical root cause of the post insert breakage is as reported, ¿the surgeon stated that the breakage of the insert was due to second fall and dislocation.¿ no additional information was provided.The patient impact is the resulting falls, multiple dislocations and closed reductions and subsequent revision.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 revealed similar events 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.A review of the instructions for use documents for knee systems revealed that the implant can break or become damaged as a result of strenuous activity or trauma.Besides, 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 has been identified as a warning and precaution and as a possible adverse effect.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.Additionally, per material specification, the quality and manufacture of standard grade polyethylene shall be controlled.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury.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: JRNY II BCS XLPE ART ISRT SZ 3-4-RT 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: 18268395
• Report Number: 1020279-2023-02387
• Device Sequence Number: 20806023
• Product Code: JWH
• UDI-Device Identifier: 00885556179017
• UDI-Public: 00885556179017
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2024

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: 74027231
• Device Lot Number: 21MM13944
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2021
• 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: 71932636/GEN II 7.5MM RESUR PAT 32MM.; 74022113/JRNY II BCS FEMORAL OXIN RT SZ 3.; 74022213/JOURNEY TIBIA BASE NP RT SZ 3.
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 65 KG