MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM TRL S/S #3LT; IMPLANT

Catalog Number 5511T301

Device Problem Crack (1135)

Patient Problem No Information (3190)

Event Date 05/26/2015

Event Type  Injury  

Event Description

Primary surgery.Upon removal of femoral trial, a crack was noticed in the lateral femoral condyle.Crack was secured with a couple of screws and surgery completed.

Manufacturer Narrative

An event regarding a periprosthetic fracture involving a triathlon ps femoral trial component was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as the component was not returned for evaluation.-medical records received and evaluation: not performed as no medical records were provided.-device history review: not performed as no lot details were provided.-complaint history review: not performed as no lot details were provided.Conclusions: the reported event involves a fracture of the femoral condyle (bone) that occurred during trialling.The fracture was fixated using several screws.The exact cause of the event could not be determined because not enough information was provided.In order to complete a full investigation, items such as device lot details, operative notes and patient history are needed to determine the root cause.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information becomes available, this investigation will be reopened.

Event Description

Primary surgery.Upon removal of femoral trial, a crack was noticed in the lateral femoral condyle.Crack was secured with a couple of screws and surgery completed.

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.Not returned to the manufacturer.

• Brand Name: TRIATHLON PS FEM TRL S/S #3LT
• 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: 4851650
• MDR Text Key: 6040024
• Report Number: 0002249697-2015-01960
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123486
• 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: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5511T301
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 60