MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN HK FEM ASSEMBLY SZ 4 LT; PROSTHESIS KNEE FEMOROTIBIAL CONSTRAINED CEMENTED METAL/POLY

Catalog Number	71421374
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
A revision surgery was performed in 2017 due to femoral component loosening.Femoral component was exchanged.An additional revision surgery was performed on 2019 due to femoral loosening.Legion system explanted.
Additional Manufacturer Narrative
Correct primary part and additional devices related.
Additional Manufacturer Narrative
The associated legion hinge femoral assembly, legion hinge link assembly, legion offset coupler, legion cemented stem, legion tibial baseplate, legion hinge post sleeve and legion guide motion articular insert were returned and evaluated.A lab analysis conducted during this investigation indicated that the examination showed signs of scratches on the femoral component, tibial insert, tibial baseplate, offset coupler, and stem.The femoral and link assembly had a great deal of relatively smooth bone cement remaining on the surface.The indentions found in the tibial insert, offset coupler, and stem were likely caused by explantation.The anterior bolt of the legion hinge sleeve was not received for analysis.The cause of the damage on the baseplate could not be determined from this investigation.No evidence of material or manufacturing deviations were observed in this investigation.Device details were provided.Therefore, the review of the manufacturing records and complaint history was conducted.The review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.The review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.There is no information that would suggest the implanted device failed to meet specifications.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.Our clinical evaluation noted that no relevant supporting clinical information has been provided to assist with a clinical investigation.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: LGN HK FEM ASSEMBLY SZ 4 LT
• Common Device Name: PROSTHESIS KNEE FEMOROTIBIAL CONSTRAINED CEMENTED METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8475269
• Report Number: 1020279-2019-01327
• Device Sequence Number: 19294130
• Product Code: KRO
• UDI-Device Identifier: 00885556108338
• UDI-Public: 00885556108338
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K081111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2019

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 Catalogue Number: 71421374
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 03/13/2019; 03/13/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 07/08/2019; 07/12/2019
• 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: 71421302 / 13EBP0084.; 71421631 / 15JBP0065.; 71421683 / 15KTM0009.; 71423345 / 16EM23312.; 71424202 / 10DSM0140.; 71424223 / UNK.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention