MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 5-6 LT 11MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL

Catalog Number	74027263
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/18/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a partial revision of left tka, i&d polyethylene insert was performed due to laceration/deep peri-prosthetic infection.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, this case reports a journey ii bcs retro study subject#: (b)(4).This event was classified as severe, possibly related to the device and procedure.Ae#:2-left knee laceration, onset (b)(6) 2015, patient presented to ed with a laceration to his left knee.He was squatting deeply when his incision split apart.Wound closure with nylon suture done, dressed.No antibiotics were given.Ae#2 deep peri-prosthetic infection, (b)(6) 2015 he presented at ed, per urging of family members.Ed physician concerned and notified operating surgeon's clinic.Seen by surgeons wound with significant drainage and local cellulitis, swelling not observed in limb.Small joint effusion.A partial revision of left tka, i&d polyethylene insert was performed on (b)(6) 2015.No clinically supporting documentation has been provided for inclusion in this investigation.Without the explant or the requested clinical information, we are unable to determine to root cause of the knee laceration/deep peri-prosthetic infection.Since this event has been reported as resolved no further clinical/medical assessment is warranted 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 parts revealed no prior complaints for the listed batches.Product was sterilized according to sterilization release documentation from quality control.Without the actual product involved and/or device information our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 5-6 LT 11MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7077430
• Report Number: 1020279-2017-01183
• Device Sequence Number: 13739328
• Product Code: JWH
• UDI-Device Identifier: 00885556178065
• UDI-Public: 00885556178065
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2018

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: Physician
• Device Expiration Date: 05/15/2023
• Device Catalogue Number: 74027263
• Device Lot Number: 13EM12055
• Initial Date Received by Manufacturer: 11/13/2017
• Supplement Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 12/01/2017
• Supplement Report FDA Received Date: 04/11/2018
• 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
• Patient Age: 63 YR