MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY UNI TIBIAL BASE RM/LL SZ 3; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71422433

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 01/14/2019

Event Type  Injury  

Event Description

A revision of a journey uni knee was performed and successfully revised it to a primary legion p/s knee.

Manufacturer Narrative

Added correct product code, catalog number and 510k.

Manufacturer Narrative

The associated complaint devices were not returned.A clinical analysis indicated that this case reports that a revision surgery was performed to revise a journey uni knee to a primary legion p/s knee.Details regarding the patient¿s weight-bearing status, medical history, bone quality, fall/trauma history, and other additional clinical relevant information have not been provided.Based on the e-mails with smith and nephew sales rep, the surgeon does not fault the product, reportedly the patient fell and injured their mcl.The future impact to the patient cannot be determine.No further clinical assessment is warranted at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed batches.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.Without the actual product involved, 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.We consider this investigation closed.

Manufacturer Narrative

"the associated complaint devices were returned and evaluated.The lab analysis concluded, the presence of bone cement left in the femur component indicates implant fixation in vivo.The scratches, dents, discoloration, and deformation observed do not present sufficient information to determine the root cause of the required revision surgery.No material or manufacturing deviations were observed in the process of this investigation.The clinical/medical team concluded, although the asd product complaint form indicated: ¿x-rays to be sent with retrieval implants¿, no images have been provided to the medical investigation team as of the date of this assessment.Per the complaint details and communication received, the surgeon did not fault the device as it was reported that the root cause of the revision was due to an injured mcl status post a traumatic fall.The product evaluation reported ¿no material or manufacturing deviations¿ were observed and did not contribute further to the medical investigation.The patient impact beyond the revision procedure could not be determined.No further medical assessment can be rendered at this time.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of complaint history for the listed part revealed no prior complaint for the listed batch.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.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: JRNY UNI TIBIAL BASE RM/LL SZ 3
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8305988
• MDR Text Key: 135032465
• Report Number: 1020279-2019-00434
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00885556029138
• UDI-Public: 00885556029138
• Combination Product (y/n): N
• PMA/PMN Number: K102069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71422433
• Device Lot Number: 18CM15210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Date Manufacturer Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR