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
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that as the surgeon was removing the femoral component from the tibial it was noticed that the assemble was broken.
Additional 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
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7805051
• Report Number: 1020279-2018-01569
• Device Sequence Number: 1510678
• Product Code: KRO
• UDI-Device Identifier: 00885556414873
• UDI-Public: 00885556414873
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K081111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2018

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 Catalogue Number: 71421631
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 11/22/2018
• 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