MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4-RT 10MM; PRSTHSIS,KNEE,PTELLOFEMOROTIBIL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR

Catalog Number	74027232
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Joint Swelling (2356)
Date of Event	10/24/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was required due to pain, swelling and joint instability.The insert was removed, the other components remained.
Additional Manufacturer Narrative
The associated complaint device was not returned.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.The clinical /medical investigation concluded that the 6-week delay in receiving physical therapy/active and passive rom post primary right tka was likely the contributing factor to the pain secondary to resultant arthrofibrosis and subsequent manipulations under anesthesia (10 weeks post-op (b)(4)).However, the reported malpositioning of the tibial component and the non-resurfaced patella with early grade 2 deformities and resultant fibrosis are also potential contributing factors to the muas and the 1st revision/poly exchange to a constrained liner (b)(4).The cultured proteus mirabilis was the contributing factor to the post-revision wound dehiscence/infection and subsequent 2nd revision debridement and smaller poly exchange.The patient impact beyond the persistent pain, arthrofibrosis, subsequent muas, 2 revisions and long-term antibiotic therapy/suppression cannot be determined.No further medical assessment can be rendered at this time.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 3-4-RT 10MM
• Common Device Name: PRSTHSIS,KNEE,PTELLOFEMOROTIBIL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 28116
• MDR Report Key: 7929018
• Report Number: 1020279-2018-01960
• Device Sequence Number: 1998614
• Product Code: JWH
• UDI-Device Identifier: 00885556169810
• UDI-Public: 00885556169810
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2019

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 Expiration Date: 06/27/2025
• Device Catalogue Number: 74027232
• Device Lot Number: 15FM23105
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 03/22/2019
• 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