MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TIBIAL COMP KIN HINGE KNEE; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, TRUNNION-BEARING

Catalog Number 64753933

Device Problems Break (1069); Insufficient Information (3190)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Injury (2348)

Event Date 11/05/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer due to hospital policy.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Patient stated they had a fall.After x-rays were taken it was stated that the rotating component had broken.

Manufacturer Narrative

An event regarding a fracture involving a krh tibial bearing component was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as no items were returned.-medical records received and evaluation: not performed as no medical information was provided.-device history review: all devices accepted into final stock conformed to specification.-complaint history review: there have been no other events for the lot referenced.Conclusions: the reported event cannot be confirmed or a root cause determined with the limited information provided.Further information such as device return, x-rays, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available, this investigation will be reopened.

Event Description

Patient stated they had a fall.After x-rays were taken it was stated that the rotating component had broken.

• Brand Name: TIBIAL COMP KIN HINGE KNEE
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, TRUNNION-BEARING
• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5251324
• MDR Text Key: 32182350
• Report Number: 0002249697-2015-04082
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2005
• Device Catalogue Number: 64753933
• Device Lot Number: IFKY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2000
• 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