MAUDE Adverse Event Report: SMITH AND NEPHEW INC GII CONST INSRT W/JRNY LOCK SZ 5-6 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71934385
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a malfunction in which there a delay over thirty minutes.The legion cross over with journey ii lock didn't have the divets in the poly for the use of the journey ii gun for insertion.
Additional Manufacturer Narrative
The associated complaint device were not returned and evaluated.The lab analysis concluded, a few scratches were noted around the anterior and lateral sides of the insert.Scratches and minor material deformation were observed on the articulating surface of the insert, and the post appeared undamaged.Per the reported complaint, divots along the anterior periphery of the insert were not present.However, these divots were never a part of this insert¿s design.No manufacturing deviations were noted on the insert.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.We consider this investigation closed.

• Brand Name: GII CONST INSRT W/JRNY LOCK SZ 5-6 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH AND NEPHEW INC; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7858736
• Report Number: 1020279-2018-01761
• Device Sequence Number: 2061939
• Product Code: JWH
• UDI-Device Identifier: 00885556084083
• UDI-Public: 00885556084083
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K962137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/21/2025
• Device Catalogue Number: 71934385
• Device Lot Number: 15BM14955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 09/09/2018
• Supplement Report FDA Received Date: 04/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1