MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HMRS ROT HINGE TIB ROT COMP; IMPLANT

Catalog Number 64832250

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 03/03/2015

Event Type  Injury  

Event Description

Dr.(b)(6) performed revision surgery as patient had a kotz rotating component which had broken.

Manufacturer Narrative

The event involves a device that is not cleared for sale in the u.S., but similar device is commercially available in the u.S.When completed, the investigation results will be submitted in a supplemental report.

Manufacturer Narrative

An event regarding component fracture involving an hmrs tibial rotating component was reported.The event was confirmed.Method & results: device evaluation and results: the post of the tibial rotating component broke in fatigue with the fracture progressing from the posterior side to the anterior side.The base metal was found to be a co, cr, mo and si alloy consistent with astm f75 material.No material or manufacturing defects were observed on the device features examined.Medical records received and evaluation: not performed as medical records were not provided.Device history review: the device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusions: the exact cause of the event could not be determined due to insufficient provision of information.Further information such as: x-rays, operative reports as well as patient history and follow up notes are needed to complete the investigation to determine root cause.

Event Description

Dr.(b)(6) performed revision surgery as patient had a kotz rotating component which had broken.

• Brand Name: HMRS ROT HINGE TIB ROT COMP
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4638404
• MDR Text Key: 5611237
• Report Number: 0002249697-2015-00944
• Device Sequence Number: 1
• Product Code: HSH
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 03/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2009
• Device Catalogue Number: 64832250
• Device Lot Number: LXNIK
• Other Device ID Number: STERILE LOT# E9171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2004
• 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: 57