MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII DISHED INS SZ 3-4 11MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71420768
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported in a register report from eprd (endoprothesenregister deutschland) that there were six revision surgeries performed to replace the insert implant genesis ii dished ins size 3-4 11mm.There is no additional information about the hospital, patient and surgery data.
Additional Manufacturer Narrative
H3, h6: the affected complaint devices, used in treatment, were not returned for evaluation.Therefore, a product analysis could not be performed.There is no information that would suggest the device failed to meet specifications.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A relationship, if any, between the device 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.The potential probable causes for this event could include but not limited to a user or procedural error.Based on this investigation, the need for corrective action is not indicated.A review of risk management files and the instructions for use found that the probable cause failures were documented appropriately.The potential probable causes for this event could include but not limited to a user or procedural error.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GII DISHED INS SZ 3-4 11MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11478946
• Report Number: 1020279-2021-02104
• Device Sequence Number: 14310316
• Product Code: JWH
• UDI-Device Identifier: 03596010209337
• UDI-Public: 03596010209337
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2021

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: 71420768
• Device Catalogue Number: 71420768
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 03/14/2021
• Supplement Report FDA Received Date: 07/29/2021
• 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; Other; Required Intervention