MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S5-6LM/RL8MM; PROSTHE, KNEE, FEMOROTIBIAL, NON-CONS, CEMENTED, METAL/POLY

Model Number	71422261
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to translation of the plastic prosthesis.The insert, baseplate and femoral component were replaced.
Event or Problem Description
It was reported that a revision surgery was performed due to translation of the plastic prosthesis.The insert was exchanged.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that, per revision report, the tibial and femoral components were well seated, however, the insert was anteriorly dislocated and the femoral component was worn.The patient crp was normal.The report of persistent pain, metal synovitis and blackened deposits are consistent with an adverse reaction to metal debris, which could have been due to the wear of the femoral component when the insert dislocated.Without the metal ions/pathology results, imaging, or the analysis of the explanted components, the source cannot be confirmed.It cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The revision findings of wear and deformity of the poly insert are consistent with the report failure.The patient¿s history of twisting of the left knee cannot be ruled out as a contributing factor.Post revision, this patient is participating in physical therapy; pain is mild and easily controlled without pain medication.No further clinical/medical assessment is warranted at this time.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes could include abnormal loading or a traumatic event.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.No further investigation is warranted for this complaint.

• Brand Name: JOURNEY UNI TIBINRT S5-6LM/RL8MM
• Common Device Name: PROSTHE, KNEE, FEMOROTIBIAL, NON-CONS, CEMENTED, METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9450295
• Report Number: 1020279-2019-04374
• Device Sequence Number: 14222519
• Product Code: HSX
• UDI-Device Identifier: 03596010582201
• UDI-Public: 03596010582201
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K061011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2020

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: No Information
• Device Model Number: 71422261
• Device Catalogue Number: 71422261
• Device Lot Number: 17GM04596
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 01/31/2020; 03/05/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 02/04/2020; 03/10/2020
• 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; Required Intervention