MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S3-4LM/RL8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71422251
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery when implanting the insert, the insert could be easily placed in the tibial baseplate slot bare-handed (without the impactor).Also, testing with bent pliers, the insert could be easily taken out of the slot.Another insert of the same code was used, but the result was the same, and it was still left inside the patient.Since there was no revision instrument at that time and the surgeon could not guarantee the revision result, the suture wound treatment was selected at that time and the long-term postoperative situation of the patient was uncertain.There was a delay of 0-30 minutes reported.
Additional Manufacturer Narrative
It was reported that during surgery when implanting the insert, the device could not be locked in place in the tibial baseplate.The surgeon left the device inside the patient.The suture of the wound was performed at that time and long-term postoperative situation of the patient is uncertain.The associated journey uni tibial insert, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.Possible causes could include but not limited to size of device or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: JOURNEY UNI TIBINRT S3-4LM/RL8MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9478623
• Report Number: 1020279-2019-04417
• Device Sequence Number: 16722670
• Product Code: HSX
• UDI-Device Identifier: 03596010582126
• UDI-Public: 03596010582126
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2020

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 Model Number: 71422251
• Device Catalogue Number: 71422251
• Device Lot Number: 19CM04664
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR