MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII ARTICULAR INSERTER/EXTRACT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED

Catalog Number 71440194

Device Problem Fracture (1260)

Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

The 510k's associated with implanted devices: k951987, k032295, k060742.

Event Description

It was reported the tip of the instrument broke during surgery and was left in the patient.The patient had to return for an additional surgery to remove the piece.

Manufacturer Narrative

Results of investigation: the associated device was returned and evaluated.A visual inspection of the returned genesis ii articular inserter/extractor confirms the stated failure.The instrument is fractured at the location of the hook feature on the handle.It is likely that the fracture was due to an overload mechanism.An overload fracture can occur if mechanical loads are applied that exceed the strength of the material.Manufactured in 2014, this instrument exhibits signs of repeated use and significant wear.A review of manufacturing records did not reveal any deviations that could have contributed to the reported issue.A review of complaint history did not reveal any previous complaints for the listed batch.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.No relevant clinical documents were provided.If additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GII ARTICULAR INSERTER/EXTRACT
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: markus poettker ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7260844
• MDR Text Key: 99613015
• Report Number: 1020279-2018-00140
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 03596010214393
• UDI-Public: 03596010214393
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71440194
• Device Lot Number: 14DM20420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: GENESIS II INSERT 71421508/17ET86698; GENESIS II TIBIA SHAFT 76547001/17ET87972; GENESIS II TIBIAL BASE 71420166/G1708700; LEGION FEMORAL COMPONENT 71423225/17EM10411
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR