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

Catalog Number UNK_REC

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

Patient Problem Injury (2348)

Event Date 07/28/2016

Event Type  Injury  

Manufacturer Narrative

An event regarding instability with malposition involving an unknown triathlon femoral component was reported.The event was confirmed through a provided operative report.Medical records received and evaluation: clinician review of the records provided indicated that femoral component malposition with flexion-extension gap space mismatch of the knee after previous revision surgery for instability caused recurrent instability.Conclusions: clinician review of the records provided indicated that femoral component malposition with flexion-extension gap space mismatch of the knee after previous revision surgery for instability caused recurrent instability.Further information such as device identification, x-rays prior to the 2012 revision, medical records and follow-up notes are required to further investigate this event.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Device not returned.

Event Description

It was reported that there was a revision surgery in (b)(6) 2012 for instability whereby an 11mm insert was exchanged for a size 16mm.

• Brand Name: UNKNOWN TRIATHLON 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: 6073605
• MDR Text Key: 58973633
• Report Number: 0002249697-2016-03446
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2016
• 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: 10/07/2016
• 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; Required Intervention
• Patient Age: 64 YR