MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY TIBIA BASE NP RT SZ 6; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	74022216
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	01/20/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented hypoxemia post operative which required hospitalization.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation, the reported event could not be confirmed.The clinical/medical team concluded, no clinically relevant supporting documentation was provided; therefore, a thorough medical investigation could not be performed.However, per the crfs, the 70yr old patient required hospitalization due to post-operative hypoxemia which resolved allowing the patient to be discharged home 7 days later.No further patient impact would be anticipated.Should clinical documentation become available in the future, the clinical/medical task may be re-evaluated.No further 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.Factors and/or potential causes that could contribute to the reported event have been identified in the risk management file.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation, the reported event could not be confirmed.The clinical/medical team concluded, no clinically relevant supporting documentation was provided; therefore, a thorough medical investigation could not be performed.However, per the crfs, the 70yr old patient required hospitalization due to post-operative hypoxemia which resolved allowing the patient to be discharged home 7 days later.No further patient impact would be anticipated.Should clinical documentation become available in the future, the clinical/medical task may be re-evaluated.No further 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 prior complaints for the listed batches/failure mode.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: JOURNEY TIBIA BASE NP RT SZ 6
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8824586
• Report Number: 1020279-2019-02748
• Device Sequence Number: 3027106
• Product Code: JWH
• UDI-Device Identifier: 03596010554307
• UDI-Public: 03596010554307
• Combination Product (Y/N): N
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Model Number: 74022216
• Device Catalogue Number: 74022216
• Device Lot Number: 16FM01796
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 06/28/2019; 06/28/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 01/29/2020; 02/25/2020
• 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