MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OXIN P/S FEM RIGHT SZ 6; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71421116
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/23/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to patient request, nothing was found to be wrong with the implants.No loosening due to cement degradation.No infection, skin was not hot to the touch.
Additional Manufacturer Narrative
Additional narrative: the associated devices were returned and evaluated.The lab analysis concluded that the components were inspected visually to determine the cause of the reported incident.No destructive analysis was conducted during this investigation.The articulating and non-articulating surfaces of the insert are scratched and worn with mild discoloration.The sides of the insert are also worn.Bone cement is still adhered to the bone cement contacting surfaces of the femoral component and of the tibial baseplate.The articulating surface and the sides of the femoral component are damaged.The tibial baseplate is worn and the proximal surface is scratched and burnished.There were no observations of material or manufacturing deviations in the course of this investigation.The medical investigation concluded that no clinically relevant information has been provided for inclusion in this investigation.Should any additional medical information be provided this complaint will be re-assessed.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.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GII OXIN P/S FEM RIGHT SZ 6
• 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: 9070338
• Report Number: 1020279-2019-03384
• Device Sequence Number: 19451649
• Product Code: JWH
• UDI-Device Identifier: 03596010469304
• UDI-Public: 03596010469304
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K962557
• 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): 11/27/2019

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 Catalogue Number: 71421116
• Device Lot Number: 17JM17450A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 11/27/2019
• 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