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
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/29/2019
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
Added product batch information.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 7-8 LT 9MM
• Common Device Name: 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
• Report Number: 1020279-2019-00696
• Device Sequence Number: 2253447
• Product Code: HWE
• UDI-Device Identifier: 00885556178317
• UDI-Public: 00885556178317
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/03/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 74027281
• Device Lot Number: 17MM06901
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 01/29/2019; 01/29/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 04/15/2019; 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention