MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN HK FEM ASSEMBLY SZ 7 LT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71421377
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that one year after implantation it was found that the connection screw 15mm was loose.Bold insert and axis from the femur size 7 were replaced.
Additional Manufacturer Narrative
Results of investigation: it was reported that one year after implantation it was found that the connection screw 15mm was loose.Bold insert and axis from the femur size 7 must be replaced.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed at this time.Our investigation including a review of manufacturing records did not reveal any deviation from the standard manufacturing processes.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.A medical analysis noted that as to date, the requested surgical records and x-rays have not been provided to fully evaluate the reported event.Therefore, no further assessment is warranted at this time.Some potential causes could include but are not limited to fit/sizing, traumatic injury, abnormal motion over time, or patient medical conditions.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: LGN HK FEM ASSEMBLY SZ 7 LT
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10722871
• Report Number: 1020279-2020-05696
• Device Sequence Number: 3525284
• Product Code: KRO
• UDI-Device Identifier: 00885556414880
• UDI-Public: 00885556414880
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2021

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 Expiration Date: 07/04/2025
• Device Model Number: 71421377
• Device Catalogue Number: 71421377
• Device Lot Number: 18FMO9216
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 02/15/2021
• 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: Required Intervention