MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II XR INS XLPE LAT 3-4 LT 8MM; PRSTHSS,KNEE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMR/MTL/PLYMR

Catalog Number	74023840
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	01/22/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a lack of range of motion and pain.Once the polys were removed, it was noticed that they show signs of wear.The patient now had great range of motion.
Additional Manufacturer Narrative
The associated complaint devices were returned.A clinical investigation concluded that this complaint is reporting a revision of a journey ii xr left knee, secondary to pain and lack of range of motion.Reportedly, once the polys were removed, it was noticed that they show excessive signs of wear and pitting.Based on the retrieval report, pitting observed on the articular surfaces of the returned journey ii xr tibial inserts may have been caused by third-body particulates, such as bone chips and/or bone cement, during articulation.Damage observed to the anterior locking detail of the insert likely occurred during insertion or extraction of the insert from the baseplate.No material or manufacturing deviations were observed during this lab analysis.The exact cause of excess wear and pitting to the inserts could not be ascertained.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal any deviations that could have caused the reported incident.All provided documents have been reviewed by the clinical investigation team.Four x-rays were provided for review, which do not indicate a reason for the excessive poly wear.With the available information, the root cause of the ¿pain and decreased range of motion¿ experienced by this patient cannot be concluded nor can the cause of the ¿signs of wear and pitting¿ be determined.No current reports on the patient¿s status have been provided.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
Additional Manufacturer Narrative
Correct implant date added.Correct explant date added.

• Brand Name: JRNY II XR INS XLPE LAT 3-4 LT 8MM
• Common Device Name: PRSTHSS,KNEE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMR/MTL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7231385
• Report Number: 1020279-2018-00101
• Device Sequence Number: 11071956
• Product Code: JWH
• UDI-Device Identifier: 00885556615652
• UDI-Public: 00885556615652
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2019

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: 05/11/2026
• Device Catalogue Number: 74023840
• Device Lot Number: 16EM10877
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 01/23/2018; 01/23/2018
• Initial Report FDA Received Date: 01/31/2018
• Supplement Report FDA Received Date: 04/11/2018; 06/20/2019
• 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; Other