MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HIGH FLEXION INSERT SZ 1-2 18MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED.

Catalog Number	71421505
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision was performed due to dissociation of insert.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.A visual examination of the scratching observed on the femoral component and tibial baseplate was likely to contact with each other following disassociation of the insert.The damage observed on the posterior region of the inferior surface of the tibial insert indicated that the insert was not fully engaged in the tibial baseplate.The anterior locking region was undeformed indicating that the insert was not fully engaged in the tibial baseplate.No manufacturing deviations were noted during this investigation.The exact cause of the insert dissociation was not able to be determined.A clinical analysis indicated that details regarding the patient¿s weight-bearing status, medical history, bone quality, fall/trauma history, and other additional clinical relevant information have not been provided.Based on the lab retrieval analysis, ¿no definite conclusion can be determined as to the exact cause of the insert dissociation¿.However, the findings of both the posterior-inferior tibial insert damage and the lack of anterior locking region deformation indicated the insert was not fully engaged in the tibial baseplate, therefore, cannot be ruled out as the contributing factor to the disassociation.Should additional information becomes available this issue can be re-elevated.No further clinical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history on the listed parts revealed no prior complaints for the listed batches.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: GII PS HIGH FLEXION INSERT SZ 1-2 18MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED.
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8065366
• Report Number: 1020279-2018-02450
• Device Sequence Number: 2141486
• Product Code: JWH
• UDI-Device Identifier: 03596010493781
• UDI-Public: 03596010493781
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2019

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 Expiration Date: 12/02/2024
• Device Catalogue Number: 71421505
• Device Lot Number: 14MM05250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 03/30/2019
• 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