MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II RESURF PAT 32MM; PRSTHSSKNEEPATLLFMRTIBLSMICNSTRINDCMNTDPLYMRMTALPLYMR

Model Number	71420576
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to loosening, osteolysis and possible chance of infection.Osteolysis was confirmed intraoperatory by the surgeon.All components were replaced with cement spacers.Primary surgery performed on (b)(6) 2012.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to loosening, osteolysis and possible chance of infection.The affected legion oxinium femoral component, genesis ii tibial baseplate, genesis ii ps high flexion insert and genesis ii resurfacing patellar component, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record and sterilization documentation review cannot be completed.There is no information that would suggest the devices failed to meet specifications.A relationship, if any, between the devices and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Without the return of the actual products involved and no patient medical records available, our investigation of this report is inconclusive.Possible causes of loosening could include but are not limited to traumatic injury, size of device or abnormal motion over time.

• Brand Name: GNS II RESURF PAT 32MM
• Common Device Name: PRSTHSSKNEEPATLLFMRTIBLSMICNSTRINDCMNTDPLYMRMTALPLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9603237
• Report Number: 1020279-2020-00314
• Device Sequence Number: 585501
• Product Code: JWH
• UDI-Device Identifier: 03596010208309
• UDI-Public: 03596010208309
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2020

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: 71420576
• Device Catalogue Number: 71420576
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 01/17/2020
• Supplement Report FDA Received Date: 05/11/2020
• 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