MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN HK FEM ASSEMBLY SZ 5 RT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71421365
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/15/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to patient's knee became unstable.Xrays showed debris.New femoral link assembly implanted.Poly was broke while retrieving broken pieces.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.A visual inspection of the polyethylene insert was reportedly fractured during revision surgery.This was reportedly done to facilitate removal of the components.The link assembly and the poly link assembly sleeve both have an identical fracture.The post sleeve is burnished on the spot that was in contact with these fractured areas.The post sleeve seems to have rubbed against the poly sleeve and link assembly, causing them to fracture.Repetitive torque on the knee joint may have been the cause of the post sleeve to become unstable and put stress on the other components.The polyethylene sleeve also shows burnishing on the side opposite of the fracture in the assembly.It was burnished until it fractured, likely due to the instability and repetitive movement of the system.The clinical/medical team concluded, without the requested x-rays, or the findings in the operative report the root cause of the reported loosening cannot be determined.In, addition, without the patient's weight bearing status, medical history, bone quality, fall/trauma history, and other additional clinical relevant information a definitive clinical root cause cannot be determined.The impact to the patient beyond the revision cannot be determined. no further clinical/medical 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 for the parts revealed no prior complaints for the listed batches.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.Credit will not be issued for the devices.

• Brand Name: LGN HK FEM ASSEMBLY SZ 5 RT
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7597992
• Report Number: 1020279-2018-01112
• Device Sequence Number: 179136
• Product Code: KRO
• UDI-Device Identifier: 00885556414934
• UDI-Public: 00885556414934
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K081111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2018

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: Health Professional
• Device Expiration Date: 05/26/2020
• Device Catalogue Number: 71421365
• Device Lot Number: 13BBP0083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 10/05/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention