MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 7-8 LT 9MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 74027281

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Pain (1994)

Event Date 01/29/2019

Event Type  Injury  

Event Description

It was reported that dr.Performed a left knee replacement on his patient on the (b)(6) 2018.She complained of persistent pain and stiffness and dr.Diagnosed her with severe arthrofibrosis.He took her back to theatre on (b)(6) 2019 and revised the femoral component to one size smaller and exchanged the insert.No more information shown.

Manufacturer Narrative

The associated journey ii bcs oxinium femoral component, journey ii bcs xlpe articular insert, genesis ii resurfacing patellar component and journey tibial baseplate were not returned for evaluation.It was reported that only the femoral component and the insert were revised.Our investigation including a review of complaint history for the revised parts revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records of the femoral component and the insert did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Without the return of the actual product involved, our investigation of this report is inconclusive.A clinical evaluation noted that no relevant documentation was provided, therefore, a thorough medical investigation could not be performed.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

Manufacturer Narrative

Added product batch information.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 7-8 LT 9MM
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8351409
• MDR Text Key: 136530760
• Report Number: 1020279-2019-00696
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00885556178317
• UDI-Public: 00885556178317
• Combination Product (y/n): N
• PMA/PMN Number: K111711
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74027281
• Device Lot Number: 17MM06901
• Date Manufacturer Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention