MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 1-2 LT 11MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number 74027223

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 09/03/2019

Event Type  malfunction  

Event Description

It was reported that after the implantation, a foreign particle was found, and it was picked up from the patient body.It was unknown if the particle was caused by the instruments or implants.

Manufacturer Narrative

The associated complaint devices were not returned.The particle associated with this complaint was returned and evaluated.The material analysis concluded that the metallic particle was a titanium alloy, which is consistent with the material used to manufacture the tibial base.The origin of the particle could not be confirmed.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual devices involved our investigation cannot proceed.If the devices or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.We consider this investigation closed.Credit cannot be issued for the devices.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 1-2 LT 11MM
• Type of Device: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9158511
• MDR Text Key: 161670523
• Report Number: 1020279-2019-03556
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556177310
• UDI-Public: 00885556177310
• Combination Product (y/n): N
• PMA/PMN Number: K111711
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 74027223
• Device Lot Number: 18HM16833
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1