MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT ADVANCED BROACH STRAIGHT SIZE 11; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 1601-1011A

Device Problems Compatibility Problem (2960); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/24/2015

Event Type  malfunction  

Event Description

Surgeon stated that he believes there is a mismatch between the broaches and the implant.

Manufacturer Narrative

When completed, the evaluation summary will be submitted in a supplemental report.

Manufacturer Narrative

The event was not confirmed.A dimensional inspection was performed on the stem and found that it is within specifications.There is no indication at this time that the design, materials, or manufacturing of the subject device contributed to the event.If additional information becomes available, this investigation will be reopened.

Event Description

Surgeon stated that he believes there is a mismatch between the broaches and the implant.

• Brand Name: SECUR-FIT ADVANCED BROACH STRAIGHT SIZE 11
• 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: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4694607
• MDR Text Key: 15973049
• Report Number: 0002249697-2015-01223
• 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: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1601-1011A
• Device Lot Number: MJPV2Y
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/25/2010
• 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