MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT MAX 127 HIP STEM #6; IMPLANT

Catalog Number 6052-0625S

Device Problem Device Expiration Issue (1216)

Patient Problem No Information (3190)

Event Date 09/09/2014

Event Type  malfunction  

Event Description

It was reported that during primary left hip surgery, an expired stem was implanted.It is still implanted in the patient.

Event Description

It was reported that during primary left hip surgery, an expired stem was implanted.It is still implanted in the patient.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device remains implanted in the patient.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Remains implanted.

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.

• Brand Name: SECUR-FIT MAX 127 HIP STEM #6
• 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: 4136708
• MDR Text Key: 4797663
• Report Number: 0002249697-2014-03727
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051738
• 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: 09/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2014
• Device Catalogue Number: 6052-0625S
• Device Lot Number: MHH81D
• Other Device ID Number: STERILE LOT# MSHHJ15A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2015
• Initial Date FDA Received: 10/02/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2009
• 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: 50 YR