MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. JRNY II BCS CNSTRD ART ISRT 3-4 RT 10M; PRSTHESIS,KNEE,PATELLOFMORTIBIL,SMICONSTRAIND,CMNTD, POLYMER/METAL/POLYMER

Catalog Number	74029232
Health Effect - Clinical Codes	Unspecified Infection (1930); Necrosis Of Flap Tissue (1972)
Date of Event	01/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient went to a knee aspiration due to infection following revision surgery.Gross purulence with sinus tract through the quadriceps.Necrotic tissue was found.Only the insert was removed.Smaller insert was implanted.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, 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); 1 week later: (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.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Product was sterilized according to sterilization release documentation from quality control.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.

• Brand Name: JRNY II BCS CNSTRD ART ISRT 3-4 RT 10M
• Common Device Name: PRSTHESIS,KNEE,PATELLOFMORTIBIL,SMICONSTRAIND,CMNTD, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis, tennessee; memphis 38116
• MDR Report Key: 7924320
• Report Number: 1020279-2018-01959
• Device Sequence Number: 13918107
• Product Code: JWH
• UDI-Device Identifier: 00885556174463
• UDI-Public: 00885556174463
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2019

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: 07/03/2023
• Device Catalogue Number: 74029232
• Device Lot Number: 13GM02982
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 03/27/2019
• 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