MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4 LT 11MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74027243
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to poly insert jumped because she sitting with her legs crossed.Poly was found slightly broken and worn.
Additional Manufacturer Narrative
H10 h2,h6: the affected journey ii bcs articular insert was returned and evaluated.A lab analysis conducted during this investigation indicated that the device showed a damaged post.Additionally, the insert showed damage on and near the insertion/extraction slot of the insert.No material or manufacturing defects were observed in any of the components in the course of this investigation.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A clinical evaluation noted that no relevant supporting documentation was provided, therefore a thorough medical investigation could not be performed.No further investigation warranted for this complaint.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 3-4 LT 11MM
• 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: 8512711
• Report Number: 1020279-2019-01557
• Device Sequence Number: 19303870
• Product Code: JWH
• UDI-Device Identifier: 00885556177716
• UDI-Public: 00885556177716
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2019

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: 74027243
• Device Lot Number: 17AM17398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 07/13/2019
• 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
• Patient Age: 55 YR