MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 3-4 9; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71421508
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/16/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on literature review "recurrent dissociation of the tibial insert after mini-subvastus posterior-stabilized total knee arthroplasty: a case report.Author: yong in¿, 1 patient presented dissociation of the tibial insert without loosening of the femoral and tibial components causing a revision surgery, same patient had a dissociation of the new tibial insert causing a 2nd revision surgery, both complications were presented while using genesis ii tka system.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation.The images provided were reviewed and could not confirm the stated failure mode.The clinical/medical investigation concluded that, without the requested patient-specific clinical information/documentation, further assessment of the reported events cannot be provided and the root cause beyond those reported in the article could not be concluded.The patient impact beyond the reported events could not be determined.No further medical assessment could be rendered at this time.Should additional clinically relevant documentation become available the medical investigation task may be re-evaluated.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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 PS HI FLEX ISRT SZ 3-4 9
• 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: 11736157
• Report Number: 1020279-2021-03584
• Device Sequence Number: 11660477
• Product Code: JWH
• UDI-Device Identifier: 03596010492357
• UDI-Public: 03596010492357
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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: 71421508
• Device Catalogue Number: 71421508
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKN GENESIS II TOTAL KNEE FEM COMP; UNKN GENESIS II TOTAL KNEE PAT COMP; UNKN GENESIS II TOTAL KNEE STEM; UNKN GENESIS II TOTAL KNEE TIB BASEPLATE
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 60