MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY UNI TIBIAL BASE LM/RL SZ 5; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71422425

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091)

Event Date 01/30/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery on left knee was performed due to pain and swelling.Patient was treated with a joint injection on (b)(6) 2018.Since the issue wasn't resolved with the injection, dr decided to perform a surgical procedure on (b)(6) 2018 to remove the parts.

Manufacturer Narrative

The associated complaint devices were not returned.The clinical/medical team concluded, the intra-operative findings noted during the revision were: pain, swelling, severe metal debris throughout the entire synovium staining all the available tissue black, and scar tissue of the patella fat pads maybe consistent with an adverse reaction to metal debris but could be a result of the disassociated liner.Without the supporting metal ion levels/pathology results, imaging, and/or the analysis of the explanted components, the cause of the failure cannot be confirmed.The patient impact beyond the revision cannot be concluded.No further clinical/medical assessment is warranted at this time.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.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.

• Brand Name: JRNY UNI TIBIAL BASE LM/RL SZ 5
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 101 hessle road; hull HU32B-N ; UK HU32BN
• MDR Report Key: 7724632
• MDR Text Key: 115187047
• Report Number: 1020279-2018-01436
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00885556088043
• UDI-Public: 00885556088043
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71422425
• Device Lot Number: 14EH192020
• Date Manufacturer Received: 07/17/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention