MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SUPER SECUR FIT; IMPLANT

Catalog Number J6051-0830

Device Problem Fitting Problem (2183)

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

Event Date 03/14/2014

Event Type  malfunction  

Event Description

When the smooth collar was attached the neck of the ssf, the smooth collar did not fit in a only a notch on one side of the stem.The stem and the smooth collar were implanted in the patient body.

Manufacturer Narrative

It was noted that the device is not available for evaluation because it remains implanted.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Manufacturer Narrative

An event regarding off label use involving an omniflex collar and super securfit stem was reported.Conclusion: the super secur-fit surgical protocol, (b)(4) outlines the specific collar size that should be used in conjunction with a specific secur-fit stem.In the reported case a size 10 collar was used in conjunction with a size 8 stem.In this case the collar size should have been selected as 8.Based on the provided information it has been determined that this event is associated with an off-label application.

Event Description

When the smooth collar was attached the neck of the ssf, the smooth collar did not fit in a only a notch on one side of the stem.The stem and the smooth collar were implanted in the patient body.

• Brand Name: SUPER SECUR FIT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3740567
• MDR Text Key: 4309071
• Report Number: 0002249697-2014-01115
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K020615
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: J6051-0830
• Device Lot Number: 43560601
• Other Device ID Number: STERILE LOT: 1305FCM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2013
• 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