MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN HK LINK ASSY SZ 2-5 FEM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71421631
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	08/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during surgery, there was a doubt if there could be a part missing from the custom implant, however surgeon was told that the device was correct and procedure continued as planned.Once the procedure was concluded, information was received that the bushing was missing from the device.A revision surgery was performed next day to add the hyper extension bushing.The current status of the patient is unknown.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms based on the information provided, the root cause was reportedly human error secondary to unfamiliarity with the custom-made hk and responsibility in obtaining/assembling the required additional standard components prior to the procedure.It was reported that actions have been instituted to mitigate similar future events involving the manufacture/assembly/shipping of custom hk components.The patient impact beyond the reported joint laxity, modified surgical procedure, and subsequent revision to insert the hyperextension stop into the femoral component could not be determined.No further medical assessment can be rendered at this time.Should clinical documentation/additional information become available, the clinical/medical task may be re-evaluated.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Possible probable cause could include but not limited the user error.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: LGN HK LINK ASSY SZ 2-5 FEM
• 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: 10551137
• Report Number: 1020279-2020-04646
• Device Sequence Number: 2992486
• Product Code: KRO
• UDI-Device Identifier: 00885556414873
• UDI-Public: 00885556414873
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71421631
• Device Catalogue Number: 71421631
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 06/28/2021
• 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: Hospitalization; Required Intervention