MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMP #2L-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5515F201

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

Patient Problems Pain (1994); Injury (2348)

Event Date 11/10/2015

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Not available.

Event Description

Per sales rep, the doctor said the patient was having pain.He had a bone scan done.The scan was lighting up showing signs for possible loosening of both femoral and tibial components.He did a revision total knee this morning.

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 device was not returned.Medical records received and evaluation: not performed as no medical records were provided.Device history review: indicated devices were manufactured and accepted into final stock on with no reported discrepancies.Complaint history review: chr confirmed that there have been no other similar events for the reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device return, operative reports, x-rays, patient history and follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.

Event Description

Per sales rep, the doctor said the patient was having pain.He had a bone scan done.The scan was lighting up showing signs for possible loosening of both femoral and tibial components.He did a revision total knee this morning.

• Brand Name: TRIATHLON PS FEM COMP #2L-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: 6070025
• MDR Text Key: 58916444
• Report Number: 0002249697-2016-03436
• 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: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: 5515F201
• Device Lot Number: S377N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2011
• 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): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 68