MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 1-2 LT 9MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	74027221
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/29/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to infection.Only insert was exchanged.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and information from the practitioner has not been provided for further consideration of this issue.No further clinical assessment can be rendered at this time no relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's current condition is unknown.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time.Bacterial infection: an acute infectious disorder caused by gram positive or gram negative bacteria.Device revision or replacement: patient required a corrective invasive procedure in which a device was replaced/revised.This includes implantable, surgically invasive (penetration through the surface of the body) or invasive (penetration though a natural body orifice or permanent artificial opening, e.G.Stoma) devices.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This included a review of sterilization documents which indicated that the product was sterilized according to sterilization release documentation.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.No further actions are being taken at this time.
Additional Manufacturer Narrative
The devices, used in treatment were not returned for evaluation, reporting event could not be confirmed.A clinical evaluation was conducted and information from the practitioner has not been provided for further consideration of this issue.No further clinical assessment can be rendered at this time no relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's current condition is unknown.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time.Bacterial infection: an acute infectious disorder caused by gram positive or gram negative bacteria.Device revision or replacement: patient required a corrective invasive procedure in which a device was replaced/revised.This includes implantable, surgically invasive (penetration through the surface of the body) or invasive (penetration though a natural body orifice or permanent artificial opening, e.G.Stoma) devices.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records 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.This included a review of sterilization documents which indicated that the product was sterilized according to sterilization release documentation.Infection is a potential complication associated with any surgery.Some potential probable causes could include contamination, patient reaction or a post-operative healing issue.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.No further actions are being taken at this time.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 1-2 LT 9MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8929128
• Report Number: 1020279-2019-03172
• Device Sequence Number: 11274557
• Product Code: JWH
• UDI-Device Identifier: 00885556177211
• UDI-Public: 00885556177211
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2020

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 Model Number: 74027221
• Device Catalogue Number: 74027221
• Device Lot Number: 18GM19187
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 07/29/2019; 07/29/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 01/03/2020; 03/03/2020
• 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: 70 YR
• Patient Weight: 64