MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OVAL RESURFACING PAT 38MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71421038
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/27/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after surgery patient had left knee pain with range of motion problems and a surgical procedure was performed.
Event or Problem Description
It was reported that after surgery patient had peroneal vein thrombosis and cellulitis in left knee.Medication therapy was used to resolve the event.
Additional Manufacturer Narrative
It was reported that after surgery patient had peroneal vein thrombosis and cellulitis in left knee.The affected journey ii articular inserts, journey ii cr oxinium femoral component, genesis ii resurfacing patella component and journey ii xr tibial baseplate, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts 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 products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident could not be corroborated.A clinical evaluation noted that no relevant supporting documentation was provided, therefore a thorough medical investigation could not be performed.Potential causes, per rmf, could include but not limited to patient reaction and patient medical history.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved and no patient medical records, our investigation of this report is inconclusive.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: GII OVAL RESURFACING PAT 38MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9315151
• Report Number: 1020279-2019-03987
• Device Sequence Number: 559846
• Product Code: JWH
• UDI-Device Identifier: 03596010485083
• UDI-Public: 03596010485083
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2020

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 Model Number: 71421038
• Device Catalogue Number: 71421038
• Device Lot Number: 18AM18589
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 10/22/2019; 01/21/2020
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 11/17/2019; 01/23/2020
• 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