MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MODULAR OFFSET QUICK CONNECT INSERTER; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 1020-1860

Device Problems Difficult to Remove (1528); Material Deformation (2976); Mechanical Jam (2983)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

When using this stem introducer with accolade ii it was extremely hard to get loose from the stem after insertion into femur.The physician needed to use a hammer to get it off of the stem and risked moving the stem.

Manufacturer Narrative

An event regarding a disassembly issue involving an accolade inserter was reported.The event was not confirmed.The device showed signs of minimal use.There was some minor deformation on the edge of the protrusion that mates with the stem and aligns it to the handle.Photographed device from function at test performed and device attached and de-tatched from accolade ii stem as seen in pictures with out any excessive force.Functional test was performed several times and the quick connect attached and released each time without any issue.Medical records received and evaluation: not performed as patient factors did not contribute to the event.All devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.There has been no other event for the lot referenced.The reported event or the root cause could not be determined because the event could not be replicated and the device was found to be fully functional.A functional test was performed and concluded that the inserter attached and detached from an accolade ii stem without any excessive force.If additional information becomes available, this investigation will be reopened.

Event Description

When using this stem introducer with accolade ii it was extremely hard to get loose from the stem after insertion into femur.The physician needed to use a hammer to get it off of the stem and risked moving the stem.

• Brand Name: MODULAR OFFSET QUICK CONNECT INSERTER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6339925
• MDR Text Key: 68038823
• Report Number: 0002249697-2017-00589
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: K122853
• 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: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1020-1860
• Device Lot Number: SC11969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2014
• 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): Other