MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OXIN P/S FEM RIGHT SZ 7; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71421117
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a revision surgery was performed due to instability.All primary implants removed except for patella.Patella left insitu.No more information available.
Additional Manufacturer Narrative
Additional information: it was reported that a revision surgery was performed due to instability.All primary implants removed except for the patella which remains implanted.The associated genesis ii np tibial baseplate, genesis ii oxinium femoral component and legion ps high flexion insert, used in treatment, were not returned for evaluation.Thus the 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.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 complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of instructions for use revealed the alleged failure is previously identified in the possible adverse events.Per our risk assessment, probable causes could include but not limited to size of device or joint laxity.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Based on this investigation, the need for corrective action is not indicated.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 OXIN P/S FEM RIGHT SZ 7
• 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: 9309487
• Report Number: 1020279-2019-03933
• Device Sequence Number: 437790
• Product Code: JWH
• UDI-Device Identifier: 03596010469311
• UDI-Public: 03596010469311
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K962557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/08/2024
• Device Model Number: 71421117
• Device Catalogue Number: 71421117
• Device Lot Number: 14HM07612
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1