MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 7-8 RT 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74027271
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924); Pain (1994); Swelling/ Edema (4577)
Date of Event	07/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka performed on (b)(6) 2014, the patient reported pain and swelling following a fall onto the knee on (b)(6) 2024.Subsequent imaging showed that the post of the jrny ii bcs xlpe art isrt sz 7-8 rt 9mm was broken off and floating in the knee.A revision surgery was performed on (b)(6) 2024 to address this adverse event, in which a new insert size 10mm was replaced.Patient's current health status is unknow.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
The associated device was returned and evaluated.The visual inspection revealed that the post fractured off.The piece was returned.The visual evaluation also reveals discoloration, scratches and gouges.The explant shows signs of significant wear and use.This inspection was conducted by naked eye.A lab analysis performed on the device revealed that the knee insert post deformation and/or fracture may have been due to repeated posterior contact of the femoral cam on the post combined with excessive posterior to anterior shear force during activity.However, this could not be isolated as the root cause for this particular failure mode.Based on the conclusions of the product history review and the device evaluation, further product evaluation is not required because there is no evidence that a manufacturing deficiency occurred.The clinical/medical investigation stated that no x-ray imaging or revision operative reports were provided for analysis.The reported fall onto the knee ((b)(6) 2024) most likely led to the post fracture as it was reported that pain and swelling occurred post injury and subsequent imaging showed that ¿the post was broken off and floating in the knee¿.Additional factors that could have contributed to the reported event include patient anatomy, abnormal loading of limb and/or excessive forces.The patient impact beyond the reported revision to a thicker insert following the traumatic fall with post-fracture could not be determined, although a transient post-operative restorative phase would be anticipated.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.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.This has been identified as a warning and precaution.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.According to the material specification, the quality and manufacture of polyethylene bar stock shall be controlled.At this time, we have no evidence to conclude that the product failed to meet any 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 for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 7-8 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: 19856314
• Report Number: 1020279-2024-01458
• Device Sequence Number: 8379826
• Product Code: JWH
• UDI-Device Identifier: 00885556179710
• UDI-Public: 00885556179710
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2024

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: 74027271
• Device Lot Number: UNKNOWN
• 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: 07/11/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 07/29/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male