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

Catalog Number 71421631

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 08/06/2018

Event Type  Injury  

Event Description

It was reported that as the surgeon was removing the femoral component from the tibial it was noticed that the assemble was broken.

Manufacturer Narrative

The associated complaint device was not returned.The clinical/medical team concluded, no relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's current condition is unknown.Therefore based on insufficient information, a clinical assessment cannot be performed at this time.Without the actual products involved, our investigation cannot proceed.Reviewing the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7805051
• MDR Text Key: 117867153
• Report Number: 1020279-2018-01569
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00885556414873
• UDI-Public: 00885556414873
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71421631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization