MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #6 R-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5510F602

Device Problems Failure To Adhere Or Bond (1031); Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348); Inadequate Osseointegration (2646)

Event Date 05/19/2016

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested.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 underwent revision for pain.Femoral component was found loose and was revised.All other components noted to be well fixed.Exchanged femur and liner.

Manufacturer Narrative

An event regarding loosening involving a triathlon femoral component was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the product was not returned.Medical records received and evaluation: not performed as no medical records were provided.Device history review: indicated the device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: indicated that there have been no other similar reported events for the lot referenced.Conclusions: the exact cause of the reported loosening could not be determined with the limited information provided.Further information such as product return, x-rays, operative notes, medical records and follow-up notes are needed to complete the investigation to determine a root cause.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.

Event Description

Patient underwent revision for pain.Femoral component was found loose and was revised.All other components noted to be well fixed.Exchanged femur and liner.

• Brand Name: TRIATHLON CR FEM COMP #6 R-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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5983665
• MDR Text Key: 55827891
• Report Number: 0002249697-2016-03074
• 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: other,study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 5510F602
• Device Lot Number: EMHYH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2015
• 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: 53 YR
• Patient Weight: 113