MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #5 L-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5510F501

Device Problems Material Too Rigid or Stiff (1544); Failure to Align (2522); Insufficient Information (3190)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 11/20/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device and additional information were not made available to the manufacturer due to hospital policy.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

Patient left knee was revised for stiffness and malalignment.

Manufacturer Narrative

An event regarding stiffness and malalignment involving a triathlon femoral component was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: not performed as no medical records were 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 similar reported events for the lot referenced.Conclusion: the exact cause of the event could not be determined as insufficient information was provided.Further information such as device return, x-rays and 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 is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Patient left knee was revised for stiffness and malalignment.

• Brand Name: TRIATHLON CR FEM COMP #5 L-CEM
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: 5307279
• MDR Text Key: 33788241
• Report Number: 0002249697-2015-04284
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• 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: 11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 5510F501
• Device Lot Number: EL83P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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: 66 YR