MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNSII CON INS SZ3-4 11MM; PRSTHSIS KNEE PATELLFEMOROTIBIA SEMCONSTRAINED CMNTD POLYMRMTAL

Catalog Number	71420524
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/05/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision on legion insert due to underside locking mechanism breaking and poly dislocating.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A visual inspection of the returned insert indicated damage on the articulating surface, with extreme damage to the distal locking face.The batch number was not visible or provided.A review of complaint history on the listed part revealed no additional complaints for the listed part with this failure mode.A lab analysis indicated that wear on the articular surface was likely due to normal articulation between the insert and femoral component.The insert disassociation likely occurred following the fracture of the posterior locking mechanism.The cause of the fracture could not be determined from the available data.Further damage to the inferior surface of the insert could have been caused by the insert riding on top of the baseplate following disassociation.No material or manufacturing deviations were observed during this investigation.A clinical analysis indicated that based on the available information, the root cause for the breakage of the locking mechanism cannot be concluded.No patient information has been provided.Based on this investigation, the need for corrective action is not indicated.No further investigation is 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.We consider this investigation closed.

• Brand Name: GNSII CON INS SZ3-4 11MM
• Common Device Name: PRSTHSIS KNEE PATELLFEMOROTIBIA SEMCONSTRAINED CMNTD POLYMRMTAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7127412
• Report Number: 1020279-2017-01274
• Device Sequence Number: 1256063
• Product Code: JWH
• UDI-Device Identifier: 03596010208040
• UDI-Public: 03596010208040
• Combination Product (Y/N): N
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2018

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: No Information
• Device Catalogue Number: 71420524
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 12/18/2017
• Supplement Report FDA Received Date: 04/11/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention