MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 132 SIZE 6 SECUR-FIT ADVANCED STEM; IMPLANT

Catalog Number 1601-06132

Device Problems Accessory Incompatible (1004); Inadequacy of Device Shape and/or Size (1583)

Patient Problem Tissue Damage (2104)

Event Date 08/04/2014

Event Type  malfunction  

Event Description

Broach did not match the stem.Broached up to a size 6 and the 6 did not fit the same, it sat about 1cm deeper.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was discarded and 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.

Manufacturer Narrative

Device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events reported for the reported manufacturing lot the event could not be confirmed nor the root cause of the reported event determined due to the minimal information received.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

Broach did not match the stem.Broached up to a size 6 and the 6 did not fit the same, it sat about 1cm deeper.

• Brand Name: 132 SIZE 6 SECUR-FIT ADVANCED STEM
• Type of Device: 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4031471
• MDR Text Key: 4875805
• Report Number: 0002249697-2014-03250
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 08/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 1601-06132
• Device Lot Number: MMLDHY
• Other Device ID Number: STERILE LOT# MSHMN12A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2013
• 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: 59 YR