MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIATHLON SIZE 5 FEMORAL COMPONENT; HIP IMPLANT

Catalog Number UNK_REC

Device Problems Malposition of Device (2616); Positioning Problem (3009)

Patient Problem Pain (1994)

Event Date 01/01/2010

Event Type  Injury  

Manufacturer Narrative

An event regarding pain due to malposition involving an unknown femoral component was reported.The event was confirmed.Method & results: device evaluation and results: could not be performed as no items associated with the event were returned or made available for identification or evaluation.Medical records received and evaluation: a review of the medical records and x-rays by the consulting clinician indicated that "the devices implanted are not subject to a recall.Early post-operative x-rays demonstrate well-fixed components with a lateral tilting patella, which is the likely cause of the complaints noted in the event description.This is not the result of factors of faulty component design, manufacturing or materials.It is most likely due to malposition of the femoral and/or tibial components in internal rotation, which could be confirmed by a ct scan of the left knee." conclusions: the exact cause of the reported pain and malposition could not be determined.A review of the medical records and x-rays by the consulting clinician indicated that "the devices implanted are not subject to a recall.Early post-operative x-rays demonstrate well-fixed components with a lateral tilting patella, which is the likely cause of the complaints noted in the event description.This is not the result of factors of faulty component design, manufacturing or materials.It is most likely due to malposition of the femoral and/or tibial components in internal rotation, which could be confirmed by a ct scan of the left knee." no further investigation for this event is possible at this time as no devices and/or insufficient information was received by stryker orthopaedics.If devices and/or additional information become available, this investigation will be reopened.

Event Description

Patient's daughter called on behalf of her father who had his left knee implanted in 2010.Patient has been experiencing pain since implantation of knee and stated the knee cap goes to the side constantly and the overall knee causes patient extreme pain since the implant surgery date in 2010.Patient wants to know if any of his devices have been recalled and investigation on manufacturing and packaging as well.Patient is currently seeing another physician and is in need of a revision surgery.

• Brand Name: UNKNOWN TRIATHLON SIZE 5 FEMORAL COMPONENT
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6041585
• MDR Text Key: 57878807
• Report Number: 0002249697-2016-03270
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 62 YR
• Patient Weight: 83