MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TIBIAL COMP KIN HINGE KNEE; IMPLANT

Catalog Number 64753933

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 12/11/2013

Event Type  Injury  

Event Description

It was reported that mrs distal femur with all poly tibia was removed due to infection.

Manufacturer Narrative

Additional devices listed in this report: cat 2481-8-010, lot eunha, description: mrs fem rot hinge lft 65mm bod; cat 6495-6-050, lot lbhxa, description: gmrs extension piece 50mm; cat 6495-6-030, lot s74jk, description: gmrs extension piece 30mm.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.It was noted that the devices are not available for evaluation.Additional information has been requested and if received, will be provided.Product not returned to manufacturer.

Manufacturer Narrative

An event regarding infection involving a tibial comp kin hinge knee was reported.The event was not confirmed.Device evaluation not performed as no items were returned.Medical evaluation not performed as no medical records were provided.Device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review.There has been no other events for the reported lot or sterile lot.The exact cause of the event could not be determined based on the limited information provided.Further information such as pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause.A capa trend analysis was conducted for the reported failure mode and concluded infection is most likely a result from other factors not necessarily related to the device in the healthcare facility setting.No further investigation is required at this time.

Event Description

It was reported that mrs distal femur with all poly tibia was removed due to infection.

• Brand Name: TIBIAL COMP KIN HINGE KNEE
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: niku kasmai ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3558245
• MDR Text Key: 15024950
• Report Number: 0002249697-2014-00068
• Device Sequence Number: 1
• Product Code: LGE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K811630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2007
• Device Catalogue Number: 64753933
• Device Lot Number: KXUR
• Other Device ID Number: STERILE LOT 02107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2002
• 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): Required Intervention
• Patient Age: 32 YR
• Patient Weight: 66